Litigation alleges that the patient suffers form pain, weakness, fatigue, elevated levels of chromium and cobalt, metallosis, instability of contra lateral hip, gait changes, bone and muscle deterioration.Update rec¿d 12(b)(6) 2014 - ppd with first page of revision medical records received.Dor and part/lot information received and updated.Post operative diagnosis of adverse tissue reaction noted.The stem and sleeve are being added to the complaint for elevated metal ion levels.Stem remained in situ.This complaint was updated on: (b)(6) 2014.
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.
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