BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE

    MDR report key: 20652377 · Received November 11, 2024

    Report

    Report Number
    0001825034-2024-02649
    Event Type
    Injury
    Date Received
    November 11, 2024
    Date of Event
    October 31, 2024
    Report Date
    April 25, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00880304240094
    PMA / PMN Number
    K052685
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - CONCOMITANT DEVICES - ORTHOPEDIC SALVAGE SYSTEM RS TIBIAL BEARING 12MM CATALOG #: 161094 LOT #: 151890. ORTHOPEDIC SALVAGE SYSTEM POLY LOCK PIN CATALOG #:150478 LOT #: 747300. ORTHOPEDIC SALVAGE SYSTEM RS POLY FEMORAL BUSHINGS CATALOG #: 161034 LOT #: 002820. ORTHOPEDIC SALVAGE SYSTEM NONMODULAR TIBIAL PLATE LONG 71MM CATALOG #: 161043 LOT #: 403920. ORTHOPEDIC SALVAGE SYSTEM RS 7CM ELLIP SEGMENTAL FEMORAL COMPONENT LEFT CATALOG #: 161010 LOT #: 049500. ORTHOPEDIC SALVAGE SYSTEM RS AXLE CATALOG #: 161035 LOT #: 683960. ORTHOPEDIC SALVAGE SYSTEM TIBIAL BUSHING CATALOG #: NI LOT #: 931960. ORTHOPEDIC SALVAGE SYSTEM BOWED IM STEM CATALOG #: NI LOT #: NI. G2 - REPORT SOURCE - FOREIGN: EVENT OCCURRED IN SPAIN. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H11. VISUAL EXAMINATION OF THE RETURNED YOKE IDENTIFIED SURFACE SCRATCHES AND BOTH FLANGE TABS HAD FRACTURED OFF THE BODY OF THE IMPLANT. DIMENSIONAL ANALYSIS OF THE RETURNED IMPLANT DETERMINED THAT THE DEVICE WAS CONFORMING TO PRINT SPECIFICATIONS WHERE MEASURED. FURTHER ANALYSIS DETERMINED THAT THE FRACTURE SURFACE SUGGESTED THE DEVICE POSSIBLY FRACTURED DUE TO FATIGUE. RADIOGRAPHIC REVIEW OF X-RAYS TAKEN PRIOR TO THE REVISION DEMONSTRATED POTENTIAL METALLIC LOOSE BODIES WITHIN THE JOINT SPACE AND ANGULATION AT THE HINGE THAT SUGGESTED POSSIBLE HARDWARE FRACTURE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS POST-OPERATIVE IMPLANT FRACTURE AND INSTABILITY APPROXIMATELY TWENTY-ONE (21) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818438 ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 163570 00880304240094

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE