Catalog Number 999890249 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Synovitis (2094); Distress (2329); Discomfort (2330)
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Event Date 03/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.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 litigation records received.Litigation alleges loosening, metallosis, synovitis, pain, discomfort and emotional distress.Doi: (b)(6) 2007; dor: (b)(6) 2021 left hip.
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.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 litigation records received.Litigation alleges loosening, metallosis, synovitis, pain, discomfort and emotional distress.Doi: (b)(6) 2007; dor: (b)(6) 2021 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: 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.3500a h10 cross reference for (b)(4): the device indicated in section d of the medwatch was also reported on (b)(4) as the patient experienced adverse events on different days with the same device.
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Event Description
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Additional information was received and stated that the patient had an infection on (b)(6) 2020.The patient had an irrigation and debridement.
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Search Alerts/Recalls
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