Catalog Number 999890149 |
Device Problem
Insufficient Information (3190)
|
Patient Problems
Host-Tissue Reaction (1297); Pain (1994)
|
Event Date 11/13/2014 |
Event Type
Injury
|
Event Description
|
Asr revision.Right
xl.Reason for revision : component loosening, alval/ soft tissue reaction, pain.Bi-lateral patient.For left side see com (b)(4).Update - added which comp loosened - stem became loose.Taken from email dated (b)(6) 2014.
|
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.(b)(4).
|
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy still considers this case closed to capa.
|
|
Event Description
|
Asr revision; right; xl; reason for revision : component loosening, alval/ soft tissue reaction, pain.Bi-lateral patient.For left side see (b)(4).Update - added which comp loosened - stem became loose.Taken from email dated 15th dec 2014.Update - attached scf, added patient date of birth.Taken from (b)(6) dated (b)(6) 2015.(b)(6).
|
|
Search Alerts/Recalls
|