Catalog Number 999800312 |
Device Problem
Degraded (1153)
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Patient Problems
Foreign Body Reaction (1868); Swelling/ Edema (4577)
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Event Date 08/30/2021 |
Event Type
Injury
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Event Description
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Asr claim and medical records received.After review of the medical records, the patient was revised to address failed left thr with placement of dual mobility component.Operative note reported a large amount of clear to slightly yellow tinted fluid within the joint.There was corrosion of mild degree at the trunnion of the femoral component and femoral prosthetic head.Doi: (b)(6) 2009; dor: (b)(6) 2021 left hip.
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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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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: previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
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Search Alerts/Recalls
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