Catalog Number 999804348 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/08/2021 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Loosening of unknown components has been alleged.There is insufficient information to determine which components were loose.Therefore, no components will be coded for loosening at this time.If/when more information is received regarding what component is loose, a supplemental med watch report will be sent.Reporter occupation: lawyer.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.
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Event Description
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Asr revision.Asr xl acetabular system, right hip.Reason(s) for revision: excessive wear secondary to loosening of an unspecified component(s).Doi: (b)(6) 2008, dor: (b)(6) 2021, right hip.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : previous investigations that have included device history reviews since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.Therefore, if lot codes are provided, no mre (device history record) review or complaint database search for this individual asr component will be carried out at this time.
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Search Alerts/Recalls
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