Catalog Number UNK HIP FEMORAL HEAD |
Device Problems
Device Dislodged or Dislocated (2923); Naturally Worn (2988)
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Patient Problems
Edema (1820); Erythema (1840); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Joint Dislocation (2374); Test Result (2695); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.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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Event Description
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Pfs and medical records received.Pfs alleges psuedotumor, dislocation, metal wear, metallosis, pain and elevated metal ions.After review of medical records, was see by physician with complaints of left thigh and knee swelling and redness.Doi: (b)(6) 2003; dor: none reported; left hip.The patient has bilateral hip implants, please see (b)(4) for the right hip.
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Manufacturer Narrative
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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 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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Manufacturer Narrative
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Udi: (b)(4).(b)(4) used to capture blood heavy metal increased.
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Search Alerts/Recalls
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