Catalog Number 122136056 |
Device Problems
Disassembly (1168); Noise, Audible (3273)
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Patient Problems
No Consequences Or Impact To Patient (2199); Not Applicable (3189)
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Event Date 05/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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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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Der states that the patient underwent total hip arthroplasty done (b)(6) 2018.It was also reported that the patient returned to office stating his hip was squeaking.X-ray showed a dissociated pinnacle liner from pinnacle cup.Cup angle measured 55 degrees of inclination.Surgeon removed the head, liner and cup.Doi: (b)(6) 2018; dor: (b)(6) 2018 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.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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