BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-3

    MDR report key: 9631390 · Received January 27, 2020

    Report

    Report Number
    0001825034-2020-00321
    Event Type
    Injury
    Date Received
    January 27, 2020
    Date of Event
    March 7, 2018
    Report Date
    February 26, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304428027
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: US157848 LOT 920380 M2A CUP 48X42MM, 157442 LOT 207660 M2A HEAD 42MM, 103203 LOT 484280 TAPERLOC FEMORAL STEM 9.0X137MM. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 04895 HEAD, 0001825034 - 2019 - 04897 CUP, 0001825034 - 2019 - 04896 STEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY AND SUBSEQUENTLY WAS REVISED NINE YEARS LATER DUE TO INCREASED PAIN AND METAL ION LEVELS, AS WELL AS OSTEOLYSIS AND BONE REMODELING DIAGNOSED ON IMAGING. DURING THE REVISION, THICKENING OF THE SYNOVIAL TISSUE AND LOCAL TISSUE REACTION WAS NOTED. AN EXTENDED TROCHANTERIC OSTEOTOMY WAS PERFORMED TO REMOVE THE FEMORAL STEM, AND A TROCHANTERIC PLATE WITH WIRES WAS REQUIRED TO STABILIZE THE FIXATION DUE TO EROSION OF THE CALCAR. THE HEAD, NECK, AND STEM WERE PLACED WITHOUT FURTHER COMPLICATION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94364 M2A-MAGNUM 42-50MM TPR INSRT-3 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 221550 00880304428027

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R