BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHK CEMENTED STEM

    MDR report key: 8394223 · Received March 6, 2019

    Report

    Report Number
    0001825034-2019-01023
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Date of Event
    July 9, 2018
    Report Date
    March 26, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD (TM) SSK FEMORAL CATALOG # 183300 LOT # 460060, AGC MODULAR POST SCREW CATALOG # 153103 LOT # 570770, BIOMET OFFSET TIBIAL TRAY ADAPTOR CATALOG # 141490 LOT # 207560 , RHK CEMENTED STEM CATALOG # 159405 LOT UNKNOWN, BIOMET OFFSET TIBIAL TRAY 67MM CATALOG # 141482 LOT # 985260 , VNGD SSKPSC TIB BRG S 16X63/67 CATALOG # 183826 LOT # 467180 , SERIES A PAT STD 31 3 PEG CATALOG # 184764 LOT 494690. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT WAS DISCARDED BY HOSPITAL. 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: 0001825034-2018-05848, 0001825034-2019-01017,, 0001825034-2019-01022 0001825034-2019-01024. DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING REVISION PROCEDURE THE TIBIAL PROSTHESIS WAS REMOVED FROM THE PATIENT AFTER SEVERAL ATTEMPTS. THE FEMORAL AND DISTAL TIBIAL COMPONENTS WERE UNABLE TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186949 RHK CEMENTED STEM KNEE PROSTHESIS JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1