Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Hypersensitivity/Allergic reaction (1907); Pain (1994); Injury (2348); Osteolysis (2377); No Code Available (3191)
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Event Date 12/10/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Us fda mdr determination: there were no reported product problems with the cup.It is reasonable to conclude that the reported patient harms are attributed to the stem corrosion and the pseudotumor which is associated with the articulating surface.(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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Medical records received.After review of medical records, the patient was revised to address a failed right total hip arthroplasty with pain, pseudotumor and increased levels of cobalt and chrome.X-rays show loosening on the calcar around the lesser trochanter.Intraoperatively there was approximately 50 cc yellowish milky fluid, osteolysis, spot welding on the proximal femur, bone loss, oxidation and blackening on the trunnion.The surgeon performed an extended trochanteric osteotomy and as the stem was being removed, the proximal calcar fractured.There was a concern that there might be an infection so the surgeon went in an implanted an antibiotic spacer.Doi: (b)(6) 2011.Dor: (b)(6) 2018, (right hip).
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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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.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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