Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.We received an asr litigation claim alleging pain, elevated blood cobalt and chromium levels, hematoma with signs of colliquation, fever, infection, inguinal abscess, swelling, pseudotumor, heart attack, walking difficulty, metallosis, injury and disability.Doi: (b)(6) 2007; dor: not indicated; left hip.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code was not provided.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Per the initial reporting; no additional investigative information will be provided.Investigational inputs were requested as indicated per internal procedures for this failure mode, however no information was provided to depuy.Without the physical complaint samples associated with this report, it was not possible to determine if the devices failed to meet specifications at the time it was released for distribution. the devices associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.Overall, from the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Brand name, common device name, lot #, part #, udi #, 510k: this report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.Initial reporter occupation: non-healthcare professional: "attorney".
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Asr litigation records received.Litigation alleges pain, elevated blood cobalt and chromium levels, hematoma with signs of colliquation, fever, infection, inguinal abscess, swelling, pseudotumor, heart attack, walking difficulty, metallosis, injury and disability.Doi: (b)(6) 2007; dor: not indicated; (left hip).
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