Catalog Number 121887352 |
Device Problems
Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ossification (1428); Adhesion(s) (1695); Pain (1994); Synovitis (2094); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/06/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.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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Event Description
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Pinnacle litigation records received.Litigation records alleges pain, injury, tissue bone destruction, wear and excessive amounts of cobalt and chromium.Doi: (b)(6) 2007 dor: (b)(6) 2021 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.Device history lot : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.Udi (b)(4).
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Event Description
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After review of medical records patient was revised to addressed failed metal on metal right hip arthroplasty.Upon incision there was notable scarring in the area.All heterotopic ossification were also excised.There was notable synovitis throughout the hip.The trunnion showed some signs of metal wear with a thick ring of black material seen at the base of the head.Doi: (b)(6) 2007 , dor; (b)(6) 2021, right hip.
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Search Alerts/Recalls
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