BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO B-MTRC MP FP SO 10

    MDR report key: 13181138 · Received January 6, 2022

    Report

    Report Number
    0001825034-2022-00058
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Date of Event
    December 21, 2021
    Report Date
    March 3, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K143009
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG#: 193009 ECHO B-MTRC MP FP SO 9 LOT#: 175900, CATALOG#: 110017102 G7 FINNED 3 HOLE SHELL 50D LOT#: 7107431, CATALOG#: 00-6250-065-30 BONE SCREW 6.5X30 SELFTAP LOT#: J7126859, CATALOG#: 110024462 G7 DUAL MOBILITY LINER 40MM D LOT#: 633890, CATALOG#: 650-1065 CER OPTION TYPE 1 TPR SLEVE -3 LOT#: 3065028, CATALOG#: 110031010 VIVACIT-E DM BEARING 28X40MM LOT#: 64782770, CATALOG#: 650-1055 CER BIOLOXD OPTION HD 28MM LOT#: 3087405. MULTIPLE REPORTS WERE SUBMITTED ALONG WITH THIS REPORT 0001825034-2022-00057. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY, THE STEM WOULD NOT SEAT. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2476168 ECHO B-MTRC MP FP SO 10 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 812450

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SEE H10 NARRATIVE