BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS REINFORCED YOKE

    MDR report key: 12780668 · Received November 9, 2021

    Report

    Report Number
    0001825034-2021-03083
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    October 27, 2021
    Report Date
    March 8, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00880304240094
    PMA / PMN Number
    K052685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT PRODUCTS: 150480 - OSS AXLE - 138980; 150476 - OSS POLY TIBIAL BUSHING - 153900; 150477 - OSS POLY FEMORAL BUSHINGS - 242510; 150478 - OSS POLY LOCK PIN - 106170; 150411 - OSS TIBIAL POLY BEARING 14 MM - 706300. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT IS UNAVAILABLE DUE TO HOSPITAL POLICY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-03084, 0001825034-2021-03085, 0001825034-2021-03086, 0001825034-2021-03087, 0001825034-2021-03088.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. APPROXIMATELY 2 MONTHS POST IMPLANTATION, THE DOCTOR REPAIRED A TORN TENDON AND EXCHANGED THE POLY, TIBIAL AND FEMORAL BUSHINGS, AXLE, YOKE AND LOCKING PIN. IT WAS REPORTED THAT NO FURTHER 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
    1681246 OSS REINFORCED YOKE PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 594230 00880304240094

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10 NARRATIVE.