Catalog Number 121720500 |
Device Problems
Loss of Osseointegration (2408); Osseointegration Problem (3003)
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Patient Problems
Pain (1994); Tissue Damage (2104); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 11/01/2010 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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.Initial reporter occupation: non-healthcare professional "attorney" (b)(4).
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Event Description
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Patient was revised to address significant metallosis and osteolysis, and pain for over one (1) year.Update in addition to previously reported allegations, it is now alleged that the patient suffers from a grossly loose acetabular cup.Update in addition to what was previously alleged, ppf alleges pseudotumor and metal wear.Doi: (b)(6) 2003; dor: (b)(6) 2010; left 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, 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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Search Alerts/Recalls
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