STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Model Number 6260-9-240 |
Device Problem
Material Erosion (1214)
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Patient Problem
Pain (1994)
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Event Date 08/27/2020 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads within scope of a capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before (b)(6) 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.
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Event Description
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It was reported by the patient's attorney as a result of a legal claim that allegedly the patient was implanted with an v40 cocr lfit femoral head on his left hip on (b)(6) 2009.It is further alleged that the patient experienced pain.X-rays allegedly showed "broken, worn out trunnion and the acetabular socket appeared to be in good condition." during revision surgery on (b)(6) 2020, "the worn out trunnion was completely corroded and wearing on a superior portion of the socket.The plastic liner was broken in this area as well.".
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