Catalog Number 121730500 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994)
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Event Date 08/08/2012 |
Event Type
Injury
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Event Description
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Update rec'd (b)(6) 2014 - sales rep reported revision surgery for the right hip.Patient was revised to address pain.The femoral stem, acetabular cup, and screw are now being added to the complaint.The complaint was updated on: (b)(6) 2014.
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.Udi: (b)(4).
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Manufacturer Narrative
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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.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Event Description
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Ppf alleges metal wear, metallosis and elevated metal ions, however metal wear and elevated metal ions were already reported.After review of medical records, patient was revised to address failed right metal on metal hip replacement, he has failed due to pain.Revision notes stated that the patient had corrosion between the metal liner and metal shell.He also had metallosis of the synovium which was mild.It was grey to light black- tinged synovium.
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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. udi: (b)(4).
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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.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.
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Search Alerts/Recalls
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