Catalog Number UNK HIP ACETABULAR CUP |
Device Problems
Nonstandard Device (1420); Loss of Osseointegration (2408); Naturally Worn (2988)
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Patient Problems
Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Test Result (2695); No Code Available (3191)
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Event Date 08/02/2017 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.(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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Asr litigation alleges that the cup produced metallic debris and had loosened resulting to pain, abnormal blood metal ion levels and walking difficulty.Doi: (b)(6) 2007; dor: (b)(6) 2017, left 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 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: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.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 will be filed as appropriate.
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Event Description
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The patient had difficulty with the hip, his cobalt and chromium ions were elevated and mri showed thickened synovium but no significant soft tissue destruction or large pseudotumor.Previous radiographs showed a lot of osteolysis in the inferior neck and was having increasing pain.After review of the medical records, the patient was revised to address failed metal on metal resurfacing arthroplasty and fracture of the femoral neck.Revision notes reported, he had some moderate trochanteric bursitis which was inflammatory and encountered fluid in the hip joint that was cloudy and stained darkly.There was an appearance of chronic metal on metal debris products with gray and blackish stained tissue.The femoral neck was fractured and the component was grossly loosed and was able to removed a lot of osteolysis.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Patient code: no code available (3191) used to capture the bursitis and device revision or replacement.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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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.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Search Alerts/Recalls
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