Litigation alleges that patient experienced pain, weakness, difficulty with simple daily living activities, inability to return to work, and increased metallic ions in his bloodstream.Revision operative note reviewed and confirmed metallosis.The revision operative note also mentions alval.In addition to what previously alleged, litigation alleged metal wear, skin rashes, weight loss, pain, increase incidence of atrial fibrillation, anxiety, thirst, loose of taste, metallic taste in saliva, and dry fragile skin.After review of medical records it was indicated that the patient present with progressive worsening left hip pain, demonstrated elevated metal ions.The patient was then revised for painful metal-sensitivity reaction to necrosis (alval).Operative notes reported that the cup was little generously anteverted and there was some erosive deficiency noted of the anterior acetabular bony wall, due to inflammatory process.
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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