Catalog Number 121725500 |
Device Problem
Osseointegration Problem (3003)
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Patient Problems
Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671)
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Event Date 10/06/2015 |
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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Ppf alleges infection, loosening of cup and metal wear.Doi: (b)(6) 2003; dor: (b)(6) 2015 (right hip) first revision.
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Event Description
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The ppf alleges infection and loosening of the cup however, after re-review of medical records, there was no confirmation of the alleged infection and loosening.
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Manufacturer Narrative
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Product complaint #: (b)(4).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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Search Alerts/Recalls
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