An article ¿revision of metal-on-metal hip arthroplasty in a tertiary center¿ by alexander d liddle eta al, reports on a prospective study of 39 hips with between 1 and 4 years of follow-up findings and outcomes of 39 consecutive painful momhas (in 35 patients) with median age 61 (25¿74) years between 2007 and 2010 revised in a tertiary unit (median follow-up time 30 (12¿54) months).The implants used for either resurfacing or total hip arthroplasty were: asr ¿ 6 hips (5 female patients).Pinnacle ¿ 1 hip.Bhr ¿ 21 hips.Cormet ¿ 5 hips.Durom ¿ 1 hip.Mitch ¿ 2 hips.Biomet ¿ 2 hips.Taperloc magnum ¿ 1 hip.Failure was happened due to following adverse factors: synovitis with negative investigations (n=3), soft tissue disruption (n=1), and solid pseudotumor (n=1).Findings were confirmed by mri.Histological examination revealed that synovitis could be suggestive of a reaction to metal debris.1 patient (2 hips) was died of an unrelated to the surgery.Asr and pinnacle were found to be associated with above reported adverse events.Case #32- (b)(6) year-old female with asr xl implantation received revision.Implanted cup inclination 57 degrees and version 35 degrees.The article clarifies she received an asr xl revision (per table 1 page 239).Noted are the following patient adverse event: revision surgery, moderate muscle destruction to abductors and moderate muscle destruction to short external rotators (per table 2 page 240).Noted are the following product adverse events: acetabular cup - mispositioned cup & femoral head, femoral augment, femoral stem - no reported product problem.
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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.H10 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 code(s) 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.Corrective action was not indicated.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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