BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL DISTAL AUGMENT CEMENTED

    MDR report key: 15240142 · Received August 17, 2022

    Report

    Report Number
    0001822565-2022-01530
    Event Type
    Injury
    Date Received
    August 17, 2022
    Date of Event
    July 16, 2020
    Report Date
    August 16, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    UDI-DI
    00889024556805
    PMA / PMN Number
    K191625
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). TWO DEVICE IDS WERE PROVIDED BY THE REPORTER; OF THESE, ONLY ONE (1) WAS REPORTED FOR REVISION PROCEDURE OCCURRED DUE TO INFECTION AND LOOSENING. IT IS UNKNOWN WHICH EXACT DEVICE ENCOUNTERED THIS ISSUE, IT IS ONE OF THE FOLLOWING: FEMORAL DISTAL AUGMENT CEMENTED ITEM#: 42556606210, LOT#: 64508941. MANUFACTURE DATE: SEP 3, 2019. STERILE EXPIRY DATE: AUG 31, 2029. UDI: (B)(4). 510K: K191625, PRO CODE: MBH. OR FEMORAL DISTAL AUGMENT CEMENTED ITEM#: 42556606210, LOT#: 64508941. MANUFACTURE DATE: SEP 3, 2019. STERILE EXPIRY DATE: AUG 31, 2029. UDI: ((B)(4). 510K: K191625, PRO CODE: MBH. MEDICAL PRODUCTS: FEMUR CEMENTED STANDARD CATALOG # 42504606201 LOT # 64683452. TIBIA FIXED CEMENTED STEM EXTENSION CATALOG # 42542007101 LOT # 64599628. FEMORAL DISTAL AUGMENT CEMENTED CATALOG # 42556606210 LOT # 64508941 QTY 1. TIBIAL AUGMENT CEMENTED HALF BLOCK CATALOG # 42555805105 LOT # 64453278 QTY 2. TIBIAL AUGMENT CEMENTED HALF BLOCK CATALOG # 42555805305 LOT # 64508912 QTY 2. ARTICULAR SURFACE FIXED BEARING CONSTRAINED CONDYLAR KNEE (CCK) CATALOG # 42512800718 LOT # 64435986. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001822565-2022-00802, 0001822565-2022-00805, 0001822565-2022-01531, 0001822565-2022-01532. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 TWO MONTHS POST IMPLANTATION DUE TO INFECTION AND LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542530 FEMORAL DISTAL AUGMENT CEMENTED PROSTHESIS KNEE MBH ZIMMER BIOMET, INC. N/A 64508941 00889024556805

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H