Catalog Number UNK HIP ACET CUP ASR |
Device Problems
Noise, Audible (3273); Illegible Information (4050)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994)
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Event Date 01/26/2021 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (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.
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Event Description
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The asr/corail hip was revised due to pain.The surgeon revised the hip, and when he got in he found that then taper on stem has been badly worn out by the asr xl and there was huge metal wear.He femoral component was damaged as seen, but well fixed.Cup also well fixed, severe metallosis in the joint.Both components changed.Postoperative uneventful course.The lot numbers are worn out, and can¿t be read on the implants.Doi: (b)(6) 2009, dor: (b)(6) 2021, left hip.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.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, no device history record (dhr) review for this individual asr component will be carried out at this point in time.
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Search Alerts/Recalls
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