BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS REINFORCED YOKE

    MDR report key: 16582798 · Received March 21, 2023

    Report

    Report Number
    0001825034-2023-00593
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    November 22, 2022
    Report Date
    July 6, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00880304240094
    PMA / PMN Number
    K052685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G3; G6; H1; H2; H3; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS SHOWS THAT THE PATIENT WAS DOING WELL AFTER THE SURGERY AND NO COMPLICATION WAS NOTED DURING PRIOR SURGERY. AFTER 4 MONTH POST-OPS, THE PATIENT EXPERIENCED PAIN, INSTABILITY, NOISE, SWELLING AND HYPEREXTENSION. X-RAY FOUND TIBIAL AXLE FLANGE FRACTURE WITH DIMINISHED BONE QUALITY. REVISION SURGERY WAS PERFORMED. DURING SURGERY, SCAR TISSUE WAS EXCISED AND NOTED ASYMMETRIC WEAR OF THE UNDERSIDE OF THE POLYETHYLENE. CONFIRMED BROKEN FLANGE. FEMUR WAS INTACT. YOKE, LOCKING PIN, AS AXLE, TIBIAL BUSHING AND TIBIAL BEARING WAS EXCHANGED. ROM WAS STABLE AND NO COMPLICATION RESULTED FROM SURGERY. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 150422 - OSS MOD TIB BASEPLATE - 489220, 150466 - OSS 7CM DIAHPYSEAL SEGMENT - 809070, 161010 - OSS RS 7 CM ELLIP SEG FMRL-LT - 584970, 161010 - OSS REINFORCED YOKE - 570110, 150476 - OSS POLY TIBIAL BUSHING - 752840, 150478 - OSS POLY LOCK PIN - 630600, 161035 - OSS RS AXLE - 994070, 161034 - OSS RS POLY FEM BUSHINGS SET/2 - 494980, 150415 - OSS TIBIAL POLY BEARING - 022530. 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 WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-00730.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A LEFT KNEE REVISION APPROXIMATELY 5 MONTHS POST IMPLANTATION DUE TO IMPLANT FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A LEFT KNEE REVISION APPROXIMATELY 5 MONTHS POST IMPLANTATION DUE TO IMPLANT FRACTURE, PAIN, INSTABILITY, NOISE, AND SWELLING. DURING THE REVISION, SCAR TISSUE AND IMPLANT WEAR WAS NOTED. THE TIBIAL BEARING, BUSHING, RS AXLE, FEMORAL BUSHINGS SET, AND LOCKING PIN WERE EXCHANGED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11488 OSS REINFORCED YOKE PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 481500 00880304240094

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10 NARRATIVE.