Legal claim received.Update rec'd 08/11/2014- litigation papers received.Litigation alleges pain, discomfort, malaise, swelling, bone and tissue damage, and elevated metal ions.The existing mdr decision has been reversed and the acetabular cup and head have been reported.The complaint was updated on: 08/19/2014.
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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.Ref.(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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