Catalog Number UNK HIP FEMORAL AUGMENT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Test Result (2695); No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary = > 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.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa (b)(4).Ongoing post market surveillance is conducted per our procedures for this product.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
(b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Asr claimsuite alert and scf received.Scf alleges right thr with asr xl done in oct 2007 with a sytemic allegation of elevated metal ions.This was created due to (b)(4) (left hip) scf that depuy product was also implanted on the right hip.Doi: (b)(6) 2007; dor: unknown; right hip.
|
|
Search Alerts/Recalls
|