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Catalog Number UNK-HIP |
Device Problems
Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)
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Patient Problems
Host-Tissue Reaction (1297); Inflammation (1932); Pain (1994); Discomfort (2330)
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Event Date 06/29/2012 |
Event Type
Injury
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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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.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 the patient had a second revision on (b)(6) 2012.No medical records were provided for this revision.Pfs alleges metal debris, alval, pseudotumor, pain, discomfort, dislocation, and elevated metal ions.The stem has already been reported on (b)(4).
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Manufacturer Narrative
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No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot codes were not provided.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.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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