Model Number 3L92511 |
Device Problem
Degraded (1153)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Pain (1994); Discomfort (2330); Injury (2348); Osteolysis (2377); No Code Available (3191)
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Event Date 09/19/2013 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.(b)(4).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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Litigation papers allege severe injury, implant failure, pain and discomfort.Plaintiff¿s preliminary disclosure form was received, which identified dob information.Part & lot were identified through patient's sticker sheet.The complaint and associated mdrs were updated.After review of medical records patient was revised to address failed left hip replacement secondary to metal adverse local tissue reaction and proximal femoral osteolysis.Revision notes reported that the acetaular and femoral component were well fixed despite the proximal femoral osteolysis.There was extensive corrosion at the taper junction between the large femoral head and the stem.There was a moderate amount of joint fluid and was some was sent for cell count and culture.The femoral head was removed with a punch and mallet and corrosion was noted as described above.
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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, 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.
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Search Alerts/Recalls
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