Catalog Number 101214030 |
Device Problems
Loss of Osseointegration (2408); Biocompatibility (2886)
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Patient Problems
Pain (1994); Inadequate Osseointegration (2646); Test Result (2695); No Code Available (3191)
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Event Date 05/29/2012 |
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.(b)(4).Initial reporter occupation: attorney.
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Event Description
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Litigation alleges that the patient suffers from pain and tenderness in hip and groin, along with several dislocations.Update 06 jul 2018 receipt of ppf and sticker sheets.In addition to what previously alleged, ppf alleges loosening of cup and stem, elevated metal ions.
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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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