Catalog Number 999890146 |
Device Problem
Insufficient Information (3190)
|
Patient Problems
Host-Tissue Reaction (1297); No Code Available (3191)
|
Event Date 03/06/2017 |
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Asr revision, asr xl, left, reason for revision: alval/soft tissue reaction.Metal ions in blood cr 2.2 & co 12.
|
|
Manufacturer Narrative
|
Asr revision asr xl left reason for revision: alval/soft tissue reaction.Metal ions in blood cr 2.2 & co 12.(b)(6) 2017: email notification from kennedys received.There is no new information added that changes the mdr reportability.This complaint was updated on: (b)(6) 2017.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|