Catalog Number 999890353 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Hypersensitivity/Allergic reaction (1907); Pain (1994); Distress (2329); Osteolysis (2377); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (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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Litigation and medical records received.Litigation records alleges emotional distress, economic loss as well as punitive damages.After review of medical records patient was revised to addressed failed right total hip arthroplasty due to pain.Mri showed significant pseudotumor and increased metal ion level with cobalt of 64 and chromium of 43.Pseudotumor that was involving her hip abductors coupled with a subsided stem that appeared to be somewhat chronic in nature with marked osteolysis of the femur.The hip was dislocated after clearing all redundant scar tissue.The stem was able to be removed with shoe clip.There was a significant pedestal present.Doi: (b)(6) 2009.Dor: (b)(6) 2019.Right hip.
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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.Device history lot: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.An mre (device history record) review will not be performed even when lot code(s) are known.
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Search Alerts/Recalls
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