Model Number 6260-9-136 |
Device Problem
Corroded (1131)
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Patient Problems
Foreign Body Reaction (1868); Cancer (3262)
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Event Date 03/19/2021 |
Event Type
Injury
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Event Description
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It was reported by patient's attorney as a result of a legal claim that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6) 2012 and was revised on (b)(6) 2021.It is further alleged that during the revision surgery the surgeon observed trunnion corrosion reaction and a pseudotumor.
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Device not returned to the manufacturer.
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Device not returned to the manufacturer.
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Event Description
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It was reported by patient's attorney as a result of a legal claim that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6) 2012 and was revised on (b)(6) 2021.It is further alleged that during the revision surgery the surgeon observed trunnion corrosion reaction and a pseudotumor.
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Search Alerts/Recalls
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