Catalog Number 999890145 |
Device Problems
Degraded (1153); Noise, Audible (3273)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994)
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Event Date 11/09/2021 |
Event Type
Injury
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Event Description
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Patient underwent primary total hip re-pavement on (b)(6) 2009 where an asr resurfacing cup with a corail stem was utilized.Patient has presented with a clunking hip in deep flexion and some pain as well as metallosis.On opening the hip, blackened tissue was evident anterior to the cup.There was some soft tissue impingement with metallosis.This black tissue was removed (pseudo tumor) and the asr 300 shell removed.The asr xl head and sleeve were removed from the stem.Corrosion was evident at the head neck junction.The stem was left in situ and a biomet dual mobility shell implanted with a new 28mm metal head.Doi: (b)(6) 2009, dor: (b)(6) 2021, unknown hip.
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Manufacturer Narrative
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(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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Additional information received indicated that there was no surgical delay and the affected side involved in this event was the right 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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