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Model Number CP260600 |
Device Problems
Fracture (1260); Unstable (1667); Detachment of Device or Device Component (2907); Migration (4003)
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Patient Problems
Failure of Implant (1924); Joint Laxity (4526)
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Event Date 11/07/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical product: unknown oss arthrodesis nail: catalog#: ni, lot#: ni; unknown oss stem: catalog#: ni, lot#: ni, qty#: 2; unknown oss connector: catalog#: ni, lot#: ni, qty#: 2.The customer has indicated that the product will not be returned to zimmer biomet for evaluation per the hospital policy.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
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Event Description
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It was reported that a patient underwent a total knee arthroplasty.Approximately three years post-implantation, the patient began to experience instability and it was determined that the locking collar disassociated.Subsequently, the patient underwent revision surgery where it was revealed that the small locking screws of the collar had backed out and one locking screw had fractured.The revision surgery was completed without complication.It was reported that no further information is available.
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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 there is a fractured screw.As no product was returned, no further evaluation can be performed.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: possible backing out of a screw at the joint space along the femoral portion.Overall fit and alignment of the implant is appropriate.Mild osteopenia.Root cause was unable to 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 at time of this report.
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Search Alerts/Recalls
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