Catalog Number L92524 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 06/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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(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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Patient presented with hip pain.X-rays showed that the stem appeared loose.The depuy stem, head and insert were removed.Surgeon noted that there was no sign of infection, however swabs were taken.A new depuy synthes marathon cup was reimplanted into the pinnacle acetabular cup.For the femoral side, the surgeon chose to implant a medacta stem and head.
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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.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.
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Search Alerts/Recalls
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