Model Number 1217-25-500 |
Device Problem
Osseointegration Problem (3003)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Weakness (2145); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).No device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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Pinnacle litigation records received.Litigation alleges pain, weakness, severe limp and limited ability to work and daily activities of living.It was also reported that the laboratory result for chromium is elevated.There is no revision reported.Doi: (b)(6) 2010; dor: not revised (left hip).Ppf alleges infection and loosening of cup.
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Manufacturer Narrative
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Product complaint # (b)(4).
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Event Description
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After review of medical records, it was indicated that the patient was revised.No additional allegations were reported.
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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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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