Pinnacle ppf and medical records received.Plaintiff profile form has no reported allegation.After the review of medical records for mdr reportability, there is no revision and complaint information reported.Once new information is received, this complaint will be updated.Doi: (b)(6) 2011; dor: not revised; left hip.
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Product complaint: (b)(4).Investigation summary: per internal procedures, the event information and any investigational inputs received as part of required follow up were reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device(s) was identified.Monitor ¿ exempt per wi-7915 - known possible complication of joint replacement surgery.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The reported event is considered one of the possible complications of joint replacement.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.- without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.- the device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event.No product contribution to the reported event was identified.No evidence was found indicating product error was a contributing factor.The need for corrective action was not indicated.Depuy considers the investigation closed.Should additional info be received, 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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