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Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Injury (2348); Joint Dislocation (2374); Osteolysis (2377); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint # (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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6 jun 2019: ¿aggressive granulomatosis of the hip: a forgotten mode of aseptic failure¿ was reviewed for mdr reportability.The study involved nine patients, including 7 patients with depuy acetabular and femoral components.Overall mean time between primary total hip arthroplasty (tha) and revision surgery was 81 months and mean follow-up since revision tha was 143 months.All patients underwent primary hip arthroplasty between april 1991 and july 2007.Two patients received competitor products.The 7 depuy hips implanted consisted of five charnley stems and two c-stem stems, as well as four duraloc uncemented cups three ogee cemented cups.Of the 7 patients with depuy hips, all 7 experienced complications and resulting revision operations.The cement used during the primary operation is unknown.The following adverse events were noted: female age (b)(6), had a revision to address a cyst, osteolysis, bone loss, metallosis, stem loosening, pain and dislocation.C-stem cdh/duraloc.
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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.Additional narrative: 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.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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