Model Number 1012-04-050 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Synovitis (2094); Discomfort (2330); Injury (2348); Osteolysis (2377); Test Result (2695); No Code Available (3191)
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Event Date 08/23/2012 |
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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Pinnacle medical records received.After review of medical records the patient was revised to addressed infected right total hip arthroplasty and extensive metallosis/alval reaction from metal on metal articulation with extensive tissue inflammation.Operative findings thick purulent material anterior and posterior hips, as well as osteolysis at the proximal femur and acetabulum.Also indicated pain, discomfort and swelling.A moderate amount of bursitis, synovitis, bone loss, debris as well.Litigation alleges elevated metal ions.Doi: (b)(6) 2008 - dor: (b)(6) 2012 (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, 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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