Model Number 42-5300-064-02 |
Device Problems
Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
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Patient Problems
Bone Fracture(s) (1870); Pain (1994); Osteopenia/ Osteoporosis (2651)
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Event Date 04/26/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: medical product: femur trabecular metal cruciate retaining (cr) standard porous: catalog#42502805402, lot#64071425; articular surface fixed bearing cruciate retaining (cr) right 10 mm height: catalog#42522000410, lot#65897421.G2: foreign: japan.Customer has indicated that the product is in process of being returned to zimmer biomet for evaluation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.
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Event Description
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It was reported that a patient underwent an initial right total knee arthroplasty.Subsequently, one week post-implantation, the patient presented at the clinic after feeling a pain.Diagnostics confirmed that the patient's proximal medial tibial bone was fractured with loosening and sinking of the tibial tray.The surgeon noted a valgus deformity and brittle bone of the patient's tibia.A revision surgery was performed to replace the tibial components without complication.It was reported that no further information is available.
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Event Description
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No further event information at 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 returned product identified signs of being implanted (scratched/nicked) along with foreign material on the distal surface.Device history record was reviewed and no discrepancies related to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: periprosthetic fracture in the medial proximal tibia adjacent to the medial tibial plate with resultant varus alignment of the knee.No signs of loosening, wear, radiolucency.There is kinking/subsidence of the medial tibial plate related to periprosthetic fracture.No contributing factors identified.Root cause was unable to be determined.This complaint is confirmed with provided medical records.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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Search Alerts/Recalls
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