Events

Field Safety Notices about Triathlon PKR Unicondylar Femoral Component Cemented – Implant, Scorpio Waffle Total Stabilized Femoral Component Tip: Left; Right– Implant, Scorpio femoral Component without LFIT and with Pegs Tip: CR Left; CR Right; PS Left; PS Right– Implant

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by HOWMEDICA INTERNATIONAL.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2014-05-09
  • Event Date Posted
    2014-06-10
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2014/10/06/obavestenje-o-meri-povlacenja-sa-trzista-medicinskih-sredstava-2/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
  • Extra notes in the data
  • Reason
    During the quality control process, the manufacturer noted, for certain lots of "triathlon" femoral and "scorpio" femoral components and restorative wedge enhancers, the incompatibility of the inner packaging with the requirements. specifically, it was found that the force required to open the inner package was less than the force prescribed by internal, validated requirements. the long-term shelf life of a sterile barrier is conditioned by the way the primary packaging is welded, that is, the stability of the sterile barrier depends on the strength with which the packaging is welded. during the quality control process, it was confirmed that the outer packaging of these medical devices was complete or undamaged. by investigation, the manufacturer has determined that the cause of the problem lies in production. the vacuum pressure of the equipment was found to be low because there was a fault on the pressure gauge as well as on the valve. by adjusting the control valve, the cause of the problem has been eliminated. possible patient complications that occur when a sterile barrier is broken are an infection that requires additional medical intervention, as well as delaying surgery if the healthcare provider notices that the packaging is poorly welded, doubts the sterility of the product, and decides to purchase another implantable medical device .

Device

Triathlon PKR Unicondylar Femoral Component Cemented – Implant, Scorpio Waffle Total Stabilized F...
  • Model / Serial
    MNH0ND (26-3005L) MNH8XR (26-3005L) MNH3V7 (26-3005L) MNHN0E (26-3005L) MNH6Y5 (26-3005R) MMR8M8 (5096-4615) MMRLYD (5096-4615) MNAYT7 (5096-4615) MMP06K (5096-5015) MNADVA (5096-5015) MMRW0J (5096-5015) MMRAWA (5096-5815) MMR7LT (5096-5815) MNA40L (5096-5815) MMR6HX (5096-5820) MMRLD7 (5096-5825) MMPW05 (5096-6225) MMRM2Y (5096-6225) MMNM07 (5096-6625) KGLX (5512-F-201) JYET (5512-F-201) KFVZ (5512-F-201) JYKX (5512-F-202) KHZL (5512-F-202) KJDN (5512-F-202) KJKY (5512-F-202) IPOP (5512-F-202) KJHI (5512-F-202) KKAE (5512-F-301) KKNB (5512-F-301) JTJA (5512-F-301) KFBY (5512-F-302) KFTZ (5512-F-302) KFXT (5512-F-302) KHAB (5512-F-302) KEYD (5512-F-302) JXXF (5512-F-302) JWGY (5512-F-401) KIED (5512-F-401) JJHT (5512-F-402) JOMB (5512-F-402) KJMO (5512-F-402) KLUP (5512-F-402) JXXM (5512-F-402) KGPE (5512-F-402) IUAJ (5512-F-402) JWPF (5512-F-402) JXMV (5512-F-501) KGKP (5512-F-501) KHWY (5512-F-502) KJBK (5512-F-502) JIML (5512-F-601) JIRX (5512-F-601) KFAS (5512-F-601) KIIY (5512-F-601) KFPI (5512-F-602) KFOS (5512-F-602) KJAG (5512-F-602) KKJW (5512-F-602) KEXE (5512-F-602) JKTF (5512-F-701) JWNL (5512-F-801) JWPY (5512-F-801) JYGID (5515-F-301) JYPJD (5515-F-301) KFWHA (5515-F-301) KIEBA (5515-F-301) KIYUD (5515-F-301) JHZRA (5515-F-301) JITNA (5515-F-301) JKEND (5515-F-301) KGAXD (5515-F-301) IVXZD (5515-F-301) JITND (5515-F-301) JJAFD (5515-F-301) JJNYA (5515-F-301) JJNYD (5515-F-301) JNSRD (5515-F-301) KFXID (5515-F-301) KGXNA (5515-F-301) KIBTA (5515-F-301) KJABD (5515-F-301) KJRID (5515-F-301) JEPOD (5515-F-301) JXBXA (5515-F-301) JYFTD (5515-F-301) JYMTD (5515-F-301) KGJTD (5515-F-301) KIGRD (5515-F-301) KJISD (5515-F-301) IVLVD (5515-F-302) JJSYA (5515-F-302) JJWNA (5515-F-302) JPFDA (5515-F-302) JVYDD (5515-F-302) JWPRA (5515-F-302) JXXZD (5515-F-302) JYBRD (5515-F-302) JYKTA (5515-F-302) JYNIA (5515-F-302) JYNID (5515-F-302) JYUED (5515-F-302) JZDWD (5515-F-302) KFNEA (5515-F-302) KFOBA (5515-F-302) KFOBD (5515-F-302) KFOHD (5515-F-302) KJFXA (5515-F-302) KJFXD (5515-F-302) IPTFD (5515-F-302) IVGVA (5515-F-302) JGIXD (5515-F-302) JIGSD (5515-F-302) JPHRA (5515-F-302) JPIWA (5515-F-302) JSZGD (5515-F-302) JYBRA (5515-F-302) JYMXA (5515-F-302) JZEHD (5515-F-302) JZFDD (5515-F-302) KGMFD (5515-F-302) KHBGA (5515-F-302) KIEXD (5515-F-302) KJBFD (5515-F-302) KJDLD (5515-F-302) KJNPA (5515-F-302) KJNPD (5515-F-302) IOLSD (5515-F-302) IPRVD (5515-F-302) JNVTA (5515-F-302) JOWJD (5515-F-302) JXBKD (5515-F-302) JXOBA (5515-F-302) JYKFD (5515-F-302) KGWGA (5515-F-302) KKJOD (5515-F-302) KGZFA (5515-F-302) IOLTD (5515-F-302) JIYVD (5515-F-302) KFVND (5515-F-302) KGMFA (5515-F-302) JPDRA (5515-F-401) JPIXD (5515-F-401) KABYA (5515-F-401) KFDKD (5515-F-401) KFMLA (5515-F-401) KGAVD (5515-F-401) KHEAA (5515-F-401) KIATA (5515-F-401) KIBVD (5515-F-401) KIFMD (5515-F-401) KJKBD (5515-F-401) JVLND (5515-F-401) JXUDD (5515-F-401) JYMUD (5515-F-401) JZDSA (5515-F-401) KIFOA (5515-F-401) KIIFA (5515-F-401) JYIDD (5515-F-401) KFPNA (5515-F-401) KHKSA (5515-F-401) KHZHA (5515-F-401) JVMTD (5515-F-401) KKFYD (5515-F-401) JIMUD (5515-F-402) JIRZD (5515-F-402) JPFEA (5515-F-402) JPGKD (5515-F-402) KGFLD (5515-F-402) KGRBA (5515-F-402) KKVHA (5515-F-402) JIFRD (5515-F-402) JKESD (5515-F-402) JOUGD (5515-F-402) KLLBD (5515-F-402) KJXDD (5515-F-402) KLBHD (5515-F-402) JYEIA (5515-F-402) KGSHD (5515-F-402) JIGXD (5515-F-402) JLVSA (5515-F-402) JLWTA (5515-F-402) KAJID (5515-F-402) KFSND (5515-F-402) KGYOD (5515-F-402) HWHLA (5515-F-501) IFDEA (5515-F-501) JIAID (5515-F-501) JKGXD (5515-F-501) JOXUA (5515-F-501) JZRRA (5515-F-501) KGIVD (5515-F-501) KGVHD (5515-F-501) KHGPA (5515-F-501) KHXWA (5515-F-501) IEXUA (5515-F-501) JPMVD (5515-F-501) KGKZA (5515-F-501) KGVPD (5515-F-501) KJGBA (5515-F-501) KKHFD (5515-F-501) KGSID (5515-F-501) KHWRD (5515-F-501) JILXA (5515-F-501) JJBFD (5515-F-501) JJTVD (5515-F-501) KFSRA (5515-F-501) KHKAD (5515-F-501) KKHFA (5515-F-501) IKEMD (5515-F-501) KLOSA (5515-F-501) JIVTA (5515-F-502) JJWSA (5515-F-502) JNVJA (5515-F-502) JXTRD (5515-F-502) KFNGD (5515-F-502) KGTMA (5515-F-502) KHGVA (5515-F-502) KHGVD (5515-F-502) KHOFD (5515-F-502) KHWVA (5515-F-502) KJGLD (5515-F-502) KKPKA (5515-F-502) KLSFD (5515-F-502) JKAAD (5515-F-502) JVUAD (5515-F-502) JXFLA (5515-F-502) JZHAD (5515-F-502) JZKTD (5515-F-502) KGYFA (5515-F-502) KHPLA (5515-F-502) KHRTA (5515-F-502) KHWMA (5515-F-502) KIDPA (5515-F-502) KIJDA (5515-F-502) KLBZA (5515-F-502) KLSFA (5515-F-502) JIEZD (5515-F-502) JPFBD (5515-F-502) KGTLA (5515-F-502) KKMDD (5515-F-502) KKOOD (5515-F-502) KKWAA (5515-F-502) KLMBA (5515-F-502) IKRKA (5515-F-502) JIDLA (5515-F-502) JIYYD (5515-F-502) JOPDD (5515-F-502) JXYSA (5515-F-502) JXBYD (5515-F-502) JMBTA (5515-F-601) JXWXA (5515-F-601) KGTDA (5515-F-601) KHJAA (5515-F-601) KHUAA (5515-F-601) KHZYA (5515-F-601) KIGND (5515-F-601) JIUMD (5515-F-601) KFISA (5515-F-601) KHFSA (5515-F-601) KHGNA (5515-F-601) KHSWA (5515-F-601) KHYED (5515-F-601) KABRD (5515-F-601) KFJXA (5515-F-601) KGBVA (5515-F-601) KHLIA (5515-F-601) IPFTA (5515-F-601) JJHZA (5515-F-601) JWFHD (5515-F-601) JWKTA (5515-F-601) KJKOA (5515-F-601) KAGLA (5515-F-601) JIYHD (5515-F-602) JIZOA (5515-F-602) JJBWD (5515-F-602) JJWPD (5515-F-602) JKERA (5515-F-602) JRBRA (5515-F-602) KEZND (5515-F-602) KFKDA (5515-F-602) KGRYD (5515-F-602) KHJTD (5515-F-602) KLKSA (5515-F-602) JKDPD (5515-F-602) JPPKD (5515-F-602) KFTMD (5515-F-602) KGNPD (5515-F-602) JPSXD (5515-F-602) KFURA (5515-F-602) KGIRA (5515-F-602) KHPZA (5515-F-602) KKXKA (5515-F-602) JYTBD (5515-F-602) MNE6NM (70-3003L) MNE963 (70-3003R) MNEKXP (70-3007L) MNE58K (70-3007L) MNE6HL (70-3007L) MNE8MN (70-3007L) MNEV2Y (70-3007R) MNEVDV (70-3007R) MNEN3D (70-3009R) MNEX43 (70-3009R) MMMXTY (70-3013L) MNE2J2 (70-4104L) MNE0Y8 (70-4104L) MNDVDT (70-4104R) MND743 (70-4104R) MNEEE4 (71-3009L) MNE12D (71-3009L) MNEALW (71-3009L) MNEXLK (71-3009L) MNEXV0 (71-3009L) MNELHM (71-3009R) MNEYNE (71-3009R) MMR24J (71-3013L) MMAKX5 (71-4104L) MNDKJ7 (71-4503R) MMT7P8 (71-4503R) MMT8J3 (71-4503R) MNE5D4 (71-4504L) MNEHV1 (71-4504L) MNEL8W (71-4504R) MND272 (71-4504R) MNDD9D (71-4504R) MNAJ78 (71-4505L) MNAN2L (71-4505L) MMT4KY (71-4505L) MMTPH5 (71-4505L) MNDP2N (71-4505L) MMTEW1 (71-4505R) MNANVA (71-4505R) MNA062 (71-4505R) MNARAR (71-4506L) MNEL1Y (71-4506L) MNEW53 (71-4506L) MNAJ1W (71-4506L) MNALJA (71-4507L) MMT9R5X1 (71-4507L) MMTJRT (71-4507L) MND1V8 (71-4507L) MMT971 (71-4507L) MNEM55 (71-4507R) MND4WP (71-4507R) MNEAAD (71-4507R) MNA17E (71-4507R) MNAHJ9 (71-4509L) MND2HL (71-4509R) MND3TN (71-4509R) MND9AE (71-4509R) MMR28L (71-4509R) MNE0LE (80-4403L) MNEJ70 (80-4403L) MNEK3L (80-4403L) MNHTRK (80-4404R) MNERD1 (80-4405L) MNEY4A (80-4405R) MNEEND (80-4405R) MNEHN0 (80-4405R) MNEK42 (80-4405R) MNEMNR (80-4405R) MNEMXH (80-4405R) MNEH40 (80-4406L) MNA4HR (80-4406L) MNE769 (80-4407L) MNEXA8 (80-4407L) MNE37L (80-4407L) MNE9RD (80-4407L) MNEATP (80-4407L) MNEX06 (80-4407L) MNELAL (80-4407R) MNEPVE (80-4407R) MNEP9K (80-4407R) MNEX9T (80-4408L) MNE7H9 (80-4409L) MNEDWK (80-4409L) MNEDXN (80-4409L) MNE0R2 (80-4409R) MNETXP (80-4409R) MNEVTV (80-4409R) MNEWN4 (80-4411L) MNEN81 (80-4411L) MNDKD0 (80-6404R) MMTA8L (80-6405R) MNA175 (80-6405R) MMRV9D (80-6407L) MMP7T5 (80-6411L) MNE34H (81-4404R) MNE9WN (81-4404R) MNEKY7 (81-4404R) MNE3XK (81-4405L) MNE40R (81-4405L) MNE50T (81-4405L) MNE6A5 (81-4405L) MNE7NN (81-4405L) MNEDX6 (81-4405L) MNERR2 (81-4405L) MNE473 (81-4405L) MNE9DD (81-4405L) MNEJ0N (81-4405L) MNELK5 (81-4405L) MNEP17 (81-4405R) MNEPET (81-4405R) MNE5W5 (81-4405R) MNEA1T (81-4405R) MNEH09 (81-4405R) MNEPX6 (81-4405R) MNER3V (81-4405R) MNEWW7 (81-4405R) MNEXDP (81-4405R) MNEXLL (81-4405R) MNEY3R (81-4405R) MNE5PE (81-4405R) MNEK9M (81-4405R) MNEA42 (81-4406L) MNENAR (81-4406L) MNEW72 (81-4406L) MNE0J3 (81-4406L) MNE5D6 (81-4406L) MNEMD4 (81-4406L) MNEMPD (81-4406L) MNEHL1 (81-4406L) MNEM0H (81-4406L) MNEMJ8 (81-4406L) MNEPN6 (81-4406L) MNE1XK (81-4406R) MNE5D2 (81-4406R) MNED3A (81-4406R) MNEA75 (81-4406R) MNEYHH (81-4406R) MNEVLY (81-4406R) MNE3KJ (81-4407L) MNE8PT (81-4407L) MNE996 (81-4407L) MNEPYY (81-4407L) MNE127 (81-4407L) MNE26L (81-4407L) MNE63T (81-4407L) MNE71T (81-4407L) MNE6XK (81-4407L) MNE2NH (81-4407R) MNED83 (81-4407R) MNENY7 (81-4407R) MNEW56 (81-4407R) MNEXV1 (81-4407R) MNE217 (81-4407R) MNELEP (81-4407R) MNENM4 (81-4407R) MNEPEP (81-4407R) MNERAV (81-4407R) MNETYX (81-4407R) MNEWN0 (81-4407R) MNEX5E (81-4407R) MNHTW5 (81-4407R) MMPE33 (81-4407R) MNE0J9 (81-4407R) MNE3MH (81-4407R) MNE9J1 (81-4407R) MNEAR2 (81-4407R) MNEAXJ (81-4407R) MNEHHE (81-4407R) MNEVN7 (81-4407R) MNEW3Y (81-4407R) MNEXVT (81-4407R) MNEYR6 (81-4407R) MNE5YP (81-4407R) MNE525 (81-4407R) MNE6WT (81-4407R) MNE7V2 (81-4407R) MNEA62 (81-4407R) MNEY27 (81-4407R) MNE2VE (81-4408L) MNEAMY (81-4408L) MNEEM0 (81-4408L) MNEYRT (81-4408L) MNEYYK (81-4408L) MNEMLA (81-4408R) MNET9J (81-4408R) MNE089 (81-4408R) MNE7XV (81-4408R) MNE8N4 (81-4408R) MNE2A1 (81-4408R) MNE4DK (81-4408R) MNE9M9 (81-4408R) MNEA4T (81-4408R) MNEAJ8 (81-4408R) MNEV0Y (81-4409L) MNEY74 (81-4409L) MNEY57 (81-4409L) MNE4W5 (81-4409L) MNEEEN (81-4409L) MNE93H (81-4409L) MNE2DK (81-4409R) MNENLJ (81-4409R) MNER77 (81-4409R) MNEV0J (81-4409R) MNE159 (81-4409R) MNE1H2 (81-4409R) MNEM2D (81-4409R) MMTVXW (81-4411R) MMP0MP (81-4413L) MMTR58 (81-6404R) MMTDN7 (81-6407L)
  • Manufacturer
    HOWMEDICA INTERNATIONAL

Manufacturer

HOWMEDICA INTERNATIONAL
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    ALIMSA