Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problems
Erosion (1750); Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)
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Event Date 01/25/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical product: van ps open intl fem-lt 67.5 catalog # 183130 lot # j6566364.Biomet cc cruciate tray 79mm catalog # 141235 lot # j6664933.Series a pat std 34 3 peg catalog # 184766 lot # 226240.1/8 quick rel drl sterile 2pk catalog # 32-486265 lot # 977300.Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2022-02207.0001825034-2022-02208.
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Event Description
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It was reported patient underwent a revision procedure one year post implantation due to pain, swelling, instability and a popping sensation in the knee.Attempt for further information has been made, but no further 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.Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical records review indicates initial surgery notes or x-ray found no complications.The patient had history of fall due to dizziness but not related to knee implants.The patient reported that the knee area feels warm to touch.Additionally, patient was noted with malrotation, pain, swelling and instability.During the revision surgery, significant anterior notch was found noted and femur component was upsized.The implants were revised without complication.Patella was retained.Post op x-ray noted lucency adjacent to the femoral prosthesis not thought to be a fracture.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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