Catalog Number 121887350 |
Device Problem
Naturally Worn (2988)
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Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
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Event Date 12/15/2016 |
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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The patient was revised for unknown reason to replace metal liner with poly liner.After review of medical records patient was revised to addressed painful right metal on metal total hip arthroplasty as well as trunnionosis.Operative notes indicated pain, elevated cobalt and chromium, limited mobility.There was significant scarring with metallosis throughout the synovium.Posterior to the metal liner, there was significant brown and black grayish colored debris.Doi: (b)(6) 2008.Dor: (b)(6) 2016 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.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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