Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Pocket Erosion (2013); Osteolysis (2377); No Code Available (3191)
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Event Date 01/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.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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After review of medical records, the patient was revised to address metallosis.Upon opening the capsule, coagulated, thick, gelatinous red/brown stained material exuded from the joint.Osteolytic material was also removed from the joint.There were some marginal erosions from the acetabulum but the bone-cement interface of the acetabulum was intact.There were erosions on the femoral side as well.Doi: (b)(6) 2009; dor: (b)(6) 2019; (left hip).
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Manufacturer Narrative
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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.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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