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Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cyst(s) (1800); Foreign Body Reaction (1868); Osteolysis (2377); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(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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On 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: male age (b)(6), had a revision to address a cyst, osteolysis, foreign body reaction.C-stem/duraloc.
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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.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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