Catalog Number 999804652 |
Device Problems
Device Dislodged or Dislocated (2923); Insufficient Information (3190); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)
|
Patient Problems
Host-Tissue Reaction (1297); Pain (1994)
|
Event Date 06/08/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.
|
|
Event Description
|
Patient underwent a revision to address alval/soft tissue reaction.
|
|
Manufacturer Narrative
|
Depuy still considers this case closed to capa.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Patient underwent a revision to address alval/soft tissue reaction, pain, subluxation, noise and elevated metal ions.
|
|
Search Alerts/Recalls
|