Catalog Number 121732048 |
Device Problems
Disassembly (1168); Loss of Osseointegration (2408); Malposition of Device (2616)
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Patient Problems
Joint Disorder (2373); Inadequate Osseointegration (2646); Not Applicable (3189)
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Event Date 02/05/2018 |
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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Removed head, cup and liner.Cup and liner were loose, surgeon thought cup might not be in optimal position.
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Manufacturer Narrative
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Product complaint # : (b)(4).
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Manufacturer Narrative
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(b)(4).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.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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