Catalog Number 999804653 |
Device Problems
Appropriate Term/Code Not Available (3191); Noise, Audible (3273)
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Patient Problem
No Information (3190)
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Event Date 08/04/2014 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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Patient underwent a revision to address elevated metal ions levels and noise.
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Manufacturer Narrative
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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, a follow-up medwatch will be filed as appropriate.
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Event Description
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Asr revision.Asr resurfacing, left.Reasons for revision : noise / increased serum concentrations from metal ions.Update - alert date 25 nov 2016.Legal claim received - (b)(6).Update ad 17 nov 2018: (b)(4) has been re-opened under (b)(4) due to receipt of claimsuite alert.Corrected lot number for the acetabular cup.Doi: (b)(6) 2006; dor:(b)(6) 2014; left hip.
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Search Alerts/Recalls
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