Claim letter and medical records received.In addition to what was previously alleged, claim letter alleges pain, popping and squeaking noise, fractured left hip liner, dislocation, implant wear, spotty black discoloration on the removed implants and scarring due to the revision.After the review of medical records, patient was revised to address dissociation and accelerated wear of ceramic femoral head.Revision notes reported black-type corrosive fluid, corroded head, wearing on the liner, oxidative black tissue and cup disassociated after removing the femoral implant.X-ray reported of abnormal liner fractured and abnormal wear.Clinical visits reported of clicking hip, eccentric placement of femoral head and hip injury.Surgical pathology reported of shiny black discoloration and fragment from acetabular component.
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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.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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