Catalog Number UNK HIP ACETABULAR LINER |
Device Problems
Naturally Worn (2988); Noise, Audible (3273)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Test Result (2695)
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Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Occupation: lawyer.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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Pfs and medical records received.Pfs alleges pain, clicking and crunching sound and blood heavy metal increased.Update 06 mar 2019 (b)(4) has been re-opened due to receipt of ppf and medical records.In addition to what previously alleged, ppf alleges metal wear and metallosis.Doi: (b)(6) 2003, dor: none, reported left hip.Cn(wipro).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.
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Event Description
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There are no unknown materials.The primary op note clearly identifies the liner as marathon poly and the head as ceramic.If metal wear is to be coded for it would have to be the stem.
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Search Alerts/Recalls
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