BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS REINFORCED YOKE

    MDR report key: 15734438 · Received November 4, 2022

    Report

    Report Number
    0001825034-2022-02493
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    October 27, 2022
    Report Date
    March 7, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304240094
    PMA / PMN Number
    K052685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCT: OSS RS 20MM LS TIBIAL BEARING CATALOG # 161098 LOT # 762730. OSS RS POLY FEM BUSHINGS SET/2 CATALOG # 161034 LOT # 462810. OSS RS AXLE CATALOG # 161035 LOT # 006970. OSS POLY LOCK PIN CATALOG # 150478 LOT # 530370. OSS POLY TIBIAL BUSHING CATALOG # 150476 LOT # 479930. REPORT SOURCE: FRANCE. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED. VISUAL EVALUATION OF THE RETURNED DEVICE SHOWS SIGNS OF REPEATED USE AND BOTH OF THE FIN FEATURES HAVE FRACTURED OFF THE FINS WERE 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 AN INITIAL LEFT TKA WAS PERFORMED ON (B)(6) 2018, WITH SUBSEQUENT REVISIONS ON (B)(6) 2021 AND (B)(6) 2022 , AND AN ASPIRATION FOR INFECTION (B)(6) 2022 . A THIRD REVISION OCCURRED ON (B)(6) 2022 DUE TO PAIN AND DISLOCATION. DURING THE REVISION IT HAD FOUND THE YOKE WINGS HAD RUPTURED, CAUSING THE HINGE TO BE UNSTABLE. THE HINGE ASSEMBLY AND TIBIAL BEARING WERE EXPLANTED AND REPLACED WITH NEW OSS DEVICES, NO COMPLICATIONS NOTED. 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 PATIENT UNDERWENT A REVISION PROCEDURE EIGHT MONTHS POST IMPLANTATION DUE TO PAIN AND TIBIAL DISLOCATION IN KNEE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    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 PATIENT UNDERWENT A REVISION PROCEDURE EIGHT MONTHS POST IMPLANTATION DUE TO PAIN AND TIBIAL DISLOCATION IN KNEE. DURING THE REVISION, IT WAS FOUND THAT THE WINGS OF THE YOKE WERE RUPTURED, MAKING THE HINGE UNSTABLE. THE HINGE WAS EXCHANGED FROM THE FEMORAL AXIS TO THE TIBIAL PIN WITHOUT COMPLICATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE 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
    2549682 OSS REINFORCED YOKE PROSTHESIS KNEE JDI ZIMMER BIOMET, INC. N/A 109010 00880304240094

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R