(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.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.
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Asr hip mom litigation record received.The litigation alleges severe pain, elevated ions level, loss of wages past and future, trouble sleeping and walking, emotional distress, and other illness and injuries.Asr hip implant was revised due to elevated levels of cobalt and chromium ions, metallosis, adverse reaction to metal debris.Revision operative note mentioned of synovitis and inflammatory tissue.Doi: (b)(6) 2009; dor: (b)(6) 2018 (left hip).
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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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