SMITH & NEPHEW, INC. ZIMMER UNICOMPARTIMENTAL TIBIAL COMPONENT PRECOAT RIGHT MEDIAL SIZE 4; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNKNOWN |
Device Problem
Fracture (1260)
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Patient Problem
Injury (2348)
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Event Date 04/01/2019 |
Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2012 a zimmer unicompartimental knee system was implanted in the right knee.The system included the femoral component high flex precoat right medial size e, tibial component precoat right medial size 4, 9 mm articular surface size 4, m/g uniheaded screw and bone cement from a competitor.The knee was re-examined in or about (b)(6) 2014, no issues found.By (b)(6) 2019, it was determined that his knee implant had fractured.Revision surgery was performed on (b)(6) 2019.The surgery involved extreme risks including potential limb amputation, additional surgeries, blood clots, and death.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The device, used in treatment, was not returned for evaluation, therefore the failure could not be confirmed.The clinical/medical team concluded, this is a legal case.All communication will be through the legal department.The medical investigation task will be closed until the documents come in to be reviewed.At that time the medical investigation will be re-opened and the investigation will proceed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, implant failure or design of device.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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