BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI OSS RS AXLE YOKE KIT

    MDR report key: 7401247 · Received April 5, 2018

    Report

    Report Number
    0001825034-2018-02422
    Event Type
    Injury
    Date Received
    April 5, 2018
    Report Date
    December 14, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01642-2; 0001825034-2018-02422-1.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OSS AVL YOKE SET WITH BUSHINGS AND CLIP CATALOG # CP115955 LOT # 852500. ANTIBIOTIC SIMPLEX - STRYKER CATALOG # 6197-9-001 LOT # MAW006, OSS TIB BLOCK 20X63/67 MR/LL CATALOG # 150429 LOT # 372750, TI OSS RS 5CM FEMUR RIGHT CATALOG # CP115952 LOT # 864080, OSS TIBIAL POLY BEARING 12MM CATALOG # 150410 LOT # 061050, TI 67MM AVL RS TIB NON MOD ING CATALOG # CP115953 LOT # 864180, COBALT G-HV BONE CEMENT 40G CATALOG # 402283 LOT # 200870, INTRAMEDULLARY PLUG XL CATALOG # 130615 LOT # 208870, OSS CEMENTED IM STEM 15X150 CATALOG # 150369 LOT # 143250, OSS TIB BLOCK 20X63/67 ML/LR CATALOG # 150430 LOT # 619560, INTRAMEDULLARY PLUG XL CATALOG # 130615 LOT # 648420. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. 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 - 2018 - 01642. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE PATIENT IS EXPERIENCING PAIN DUE TO THE ASSEMBLY OF THE PROSTHESIS FRACTURING. THE REVISION HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244193 TI OSS RS AXLE YOKE KIT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 852700

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention