Patient contacted depuy as a result of the asr recall to initiate a claim.Medical records were obtained.Medical records indicate patient was revised due to pain.Upon revision, metallosis debris and insignificant bone ingrowth on the acetabular cup were noted.Update rec'd 11/26/2014- litigation papers received.Litigation alleges pain, tissue damage from metallosis, and cobalt and/or chromium poisoning.The doi was provided.The stem and sleeve are being added to the complaint.There is no new additional information that would affect the investigation.The complaint was updated on: 11/22/2014.
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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.Wwcapa (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.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.
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