Catalog Number 999890247 |
Device Problems
Naturally Worn (2988); Noise, Audible (3273)
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Patient Problems
Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/07/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.
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Event Description
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Asr xl litigation records received.Litigation alleges pain, injury, elevated cobalt and chromium level, acetabular cup detached/ disconnected, metal debris, loosened acetabulum, walking difficulty, grinding and clicking.Doi: (b)(6) 2007.Dor: (b)(6) 2020; (left 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 manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
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Event Description
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After review of the medical records, the patient was revised to address failed left total hip arthroplasty secondary to adverse metal on metal reaction and cobalt chromium toxicity.Revision notes reported of moderate alval limited to the capsule and moderate capsular necrosis.It was also indicated that there was a small hip effusion around the femoral neck and mild synovial thickening.Laboratory results showed elevated cobalt serum level.Stem was not revised during revision.Doi: (b)(6) 2007.Dor: (b)(6) 2020.(left hip).
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Udi : (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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