BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHK AXLE

    MDR report key: 8775508 · Received July 10, 2019

    Report

    Report Number
    3002806535-2019-00596
    Event Type
    Injury
    Date Received
    July 10, 2019
    Date of Event
    April 30, 2019
    Report Date
    October 17, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT PROCEDURE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO RHK AXLE FRACTURE, CAUSING IMPLANT LOOSENING.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT PROCEDURE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO RHK AXLE FRACTURE, CAUSING IMPLANT LOOSENING.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: BMT SPLINED KNEE STM 14X160 BO, CATALOG #: 141874, LOT #: 377140; MEDICAL PRODUCT: RHK LEFT SML RESURFACING FEMUR, CATALOG #: 154978, LOT #: 2317128; MEDICAL PRODUCT: RHK MODULAR TIBIAL 63MM, CATALOG #: 154987, LOT #: 2579725; MEDICAL PRODUCT: RHK 10X120 CEMENTED STEM, CATALOG #: 159414, LOT #: 594819; MEDICAL PRODUCT: AGC V2 HPPS INTLK TIB 87X16, CATALOG #: 158998, LOT #: 2540001; MEDICAL PRODUCT: RHK FEMORAL BUSHES UHMWPE, CATALOG #: 154974, LOT #: 2614505; MEDICAL PRODUCT: RHK TIBIAL BUSH, CATALOG #: 154973, LOT #: 2649206; MEDICAL PRODUCT: RHK BEARING 12 FOR 63-67 TRAY, CATALOG #: 159430, LOT #: 2600524; MEDICAL PRODUCT: RHK SHORT YOKE, CATALOG #: 154997, LOT #: 2633685. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570290 RHK AXLE KNEE PROSTHESIS JWH BIOMET UK LTD. N/A 2540001

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R