Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Ambulation Difficulties (2544); Joint Laxity (4526)
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Event Date 07/10/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: 161094 - oss rs 12mm ls tibial bearing - (b)(6); 150476 - oss poly tibial bushing - (b)(6); 161034 - oss rs poly fem bushings set/2 - (b)(6); 150478 - oss poly lock pin - (b)(6); 150493 - oss reinforcd yoke - (b)(6); 150427 - oss tib blk aug 10x71/75 univ - (b)(6); 150427 - oss tib blk aug 10x71/75 univ - (b)(6); 150400 - oss porous im stem 21.5 x 150 - (b)(6); 161041 - oss rs non-mod plt long 71 - (b)(6); 161014 - oss rs 8.5cm ellip seg fmrl-lt - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01779, 0001825034-2023-01780, 0001825034-2023-01781, 0001825034-2023-01782, 0001825034-2023-01784.
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Event Description
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It was reported that the patient underwent an initial knee surgery.Subsequently, the patient presented with left knee pain and instability approximately five years postop and underwent a revision surgery.The bearing and bushing kit were revised.Attempts have been made and all available information has been provided.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified explanted axle, yoke, bushings and bearing.The polyethylene bearing is worn unevenly.The bushings and the bearing also show signs of damage and fracture.It is assumed to be caused by the explanation of the devices but unknown.The device history record was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: polyethylene wear, two radio-opaque objects are noted not connected to the implants, bone quality is osteopenic, no evidence of implant loosening.Lateral polyethylene wear with valgus malalignment as noted.This could result in pain/instability.A definitive root cause cannot 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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was further reported that the patient reported clunking, instability, and pain and was revised.During the revision, the poly insert was noted to be broken.No intraoperative complications reported.From provided images, the yoke and tibial bushing were also fractured.Attempts have been made and all available information has been provided.
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Search Alerts/Recalls
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