Catalog Number UNK HIP FEMORAL HEAD |
Device Problems
Corroded (1131); Degraded (1153); Device Dislodged or Dislocated (2923)
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Patient Problems
Joint Dislocation (2374); No Code Available (3191)
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Event Date 03/24/2014 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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"the literature article entitled, ""do you have to remove a corroded femoral stem"" writtne by nitin goyal, md, henry ho, ms, kevin b.Fricka, md, and charles a.Engh jr.Md published by the journal of arthroplasty 29 suppl.2 (2014) 139-142 accepted by publisher 24 march 2014 was reviewed.The article's purpose was to report upon 86 retrieved femoral heads with note of corrosion while leaving a well fixed stem in place regardless of the degree of corrosion.All implants were depuy products without provision of identified platforms.The article reports all retrieved femoral heads were related to revision surgeries associated with poly wear.No further information provided on original revision reasons.The article does not provide information if corrosion was noted on the femoral stem.The article reports after revision surgery and exchange of heads and liners, 7 re-revisions were provided with reasons along with any note of corrosion on femoral head taper which are captured individually in linked complaints.Depuy products utilized: cocr femoral head, poly liner, cocr stem.No information provided for acetabular cup." this complaint captures case 1 that required re-revision.31 years from initial revision for recurrent dislocation/subluxation with note of moderate corrosion on 2nd retrieved ball.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: corrected: h6 (closure codes and device codes).Product complaint (b)(4).Investigation summary : 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 number was 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.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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