Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 10/04/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a uni knee arthroplasty and approximately 4 months later a revision surgery was performed due to disease progression and pain.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).D10 ¿ medical devices: oxford ph3 cementless fem sz l; item# 154927; lot# 7371581.Oxf uni cmntls tib sz d rm; item# 166577; lot# 7331854.G2 ¿ foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00361 and 3002806535 - 2023 - 00363.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified that the femoral implant has bone ingrowth on the porous posterior facet with signs of cortical bone present, the tibial implant has bone ingrowth on the porous distal face with less towards the posterior edge.No further information can be gleaned from the provided pictures.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Devices are used for treatment.Radiographs were provided and reviewed by a radiologist.The review identified a medial unicompartmental arthroplasty is present.There is radiolucency along the posterior flange of the femoral implant which appears posteriorly positioned and not fully seated against the posterior medial femoral condyle.The tibial implant is also posteriorly positioned in relation to the tibial plateau.There is no fracture.Radiolucency along the posterior flange of the right knee medial unicompartmental arthroplasty with posterior position of the femoral and tibial implants as noted.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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