Catalog Number 999800748 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Renal Failure (2041); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544); Metal Related Pathology (4530)
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Event Date 03/28/2022 |
Event Type
Injury
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Event Description
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Asr xl litigation complaint received ad 3 jan 2023.Patient was revised due to pain, discomfort, increase metal levels in blood including cobalt and chromium, permanent injuries, emotional distress, disability and disfigurement.Doi: (b)(6) 2006.Dor: (b)(6) 2022.Left hip.
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Manufacturer Narrative
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Product complaint # (b)(4).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.The device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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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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 : device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
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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.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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Event Description
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Plaintiff fact sheet received.After review, the patient was revised due to hip pain caused by walking and standing, chromium and cobalt metal levels were tested and were found to be high, metallosis, and corrosion was found at the taper according to surgeon, sleeping difficulties in which laying on my right side caused it.The patient was feeling angry and have anxiety about all of the damage that the asr has caused and about any future damage the metallosis may cause and also concerned that the elevated levels of chromium and cobalt caused damage to his kidneys and other organs.
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Search Alerts/Recalls
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