Events

Field Safety Notices about DePuy Articular Surface Replacment System ASR Unipolar Femoral Implants, DePuy Articular Surface Replacment System Total ASR Acetabular Implants, DePuy Articular Surface Replacment System ASR Tapered Sleeve Adaptor

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

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
    2010-08-24
  • Event Date Posted
    2012-01-30
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2012/01/30/povlacenje-medicinskog-sredstva-de-puy/
  • 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
    After receiving new data from the uk that demonstrated the asr system had a higher than expected revision rate at 8-9 percent at three years when used with smaller head sizes (less than 50 mm diameter). the overall revision rate for asr continued to be in line with the class of metal-on-metal monoblock systems based on the data available to depuy at that time. depuy has just recevied new, unpublished 2010 data from the national joint registry (njr) of england and wales. the data shows the five year revision rate for asr hip resurfacing system is approximately 12 percent and for the asr xl acetabular system is approximately 13 percent. these revision rates are across the entire size range. the risk for revision was highest with asr head sizes below 50 mm in diameter and among female patiens.*do not implant the acr devices.

Device

DePuy Articular Surface Replacment System ASR Unipolar Femoral Implants, DePuy Articular Surface ...

Manufacturer

De Puy International Limited