Catalog Number UNK HIP FEMORAL HEAD |
Device Problems
Naturally Worn (2988); Noise, Audible (3273)
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Patient Problems
Foreign Body Reaction (1868); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Test Result (2695); Not Applicable (3189); 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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An article ¿one component revision of failed hip resurfacing from adverse reaction to metal wear debris¿ by james w pritchett et al reports on the results of 90 one- component revisions in 89 patients (46 males, 43 females; mean age 49.8years) for failed hip resurfacing due to adverse reaction to metal wear debris (76 acetabular, 14 femoral).The following primary resurfacing components were used - birmingham hip resurfacing system, conserve plus total resurfacing hip system, cormet hip resurfacing system, asr hip resurfacing system, recap total hip resurfacing system, durom hip resurfacing system.The asr hip resurfacing system was employed in 8 cases.All cases of revision surgery were presented with pain, noise, instability, effusion and elevated blood cobalt levels.Failure was happened due to acetabular fracture, continuing metallosis, infection and loose acetabulum let to revision surgery.Histological examination of peri prosthetic tissues of all patients confirmed an adverse reaction to metal debris.Extensive fibrinous necrosis was found in most cases.No clarification was found on which events were specifically present on specific patients.Asr hip resurfacing system was found to be associated with above reported adverse events.
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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.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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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