Events

Recall of DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis ImplantsModular Centered Epiphysis Size 1 HAModular Eccentric Epiphysis Size 1 Left HAModular Eccentric Epiphysis Size 1 Right HAModular Centered Epiphysis Size 2 HAModular Eccentric Epiphysis Size 2 Left HAModular Eccentric Epiphysis Size 2 Right HA

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-01218-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01218-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    An investigation by johnson & johnson medical determined that certain lots produced in a specific machine were manufactured in a manner in which the post’s diameter is out-of-specification. further investigation determined that the issue is related to the circularity of the cylinder. the circularity issue may cause the epiphysis to interfere with the stem and the two implants (epiphysis and stem) cannot be assembled. six (6) complaints were received worldwide within approximately a one month period. the current complaint rate associated with this failure mode is 0.0260%.If the epiphysis does not assemble to the stem and an alternative device is available, there may be a surgical delay of 15 to 59 minutes.Or, if an alternative implant is not available, the patient’s wound may need to be closed and the patient scheduled for a reoperation when a suitable device is available. note: once the epiphysis is properly assembled to the stem, there is no additional risk to the patient.
  • Action
    1. Users are to inspect the device(s) in your possession to determine if they possess affected product. If so quarantine this product prior to returning it to JJM. Return a copy of the supplied completed acknowledgement form as directed. 2. Return any affected product within 30 business days, by contacting JJM Customer Service on 1300 562 711. You may wish to request assistance from your JJM DePuy Synthes Representative. 3. Forward this notice to anyone in your facility who needs to be informed. 4. If any potentially affected product(s) has been forwarded to another facility, contact that facility to arrange inspection and return (if applicable). 5. Keep a copy of the customer letter until actions are completed. 6. JJM will also write to implanting surgeons to advise them of this and the non-risk it presents to implanted devices.

Device

DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis ImplantsModular Cent...
  • Model / Serial
    DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis ImplantsModular Centered Epiphysis Size 1 HAModular Eccentric Epiphysis Size 1 Left HAModular Eccentric Epiphysis Size 1 Right HAModular Centered Epiphysis Size 2 HAModular Eccentric Epiphysis Size 2 Left HAModular Eccentric Epiphysis Size 2 Right HAMultiple Part and Lot NumbersARTG Number: 143529
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes