Pinnacle medical record received.After review of medical records the patient was revised to address pain and recalled asr.Operative note reported efflux of mild amount of cloudy non-purulent fluid, less scar tissue, mild amount of metallosis around trunnion, no bony ingrowth to the back of the cup, minimal bone loss, short 1 mm to the right lower extremity compared to the left.Doi: (b)(6) 2011; dor: (b)(6) 2011 (right hip, second revision).
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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.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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