BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-6

    MDR report key: 9465647 · Received December 13, 2019

    Report

    Report Number
    0001825034-2019-05559
    Event Type
    Injury
    Date Received
    December 13, 2019
    Date of Event
    May 24, 2018
    Report Date
    December 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: M2A-MAGNUM MOD HD SZ 42MM, PN 157442, LN 024950. M2A-MAGNUM PF CUP 48ODX42ID PN US157848, LN 990820. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-05554, 0001825034-2019-05558. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN INITIAL LEFT THA. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 11 YEARS AFTER THE INITIAL SURGERY DUE TO METALLOSIS, PAIN, TISSUE DAMAGE, BONE LOSS, DECREASE IN ACTIVITIES OF DAILY LIVING, LOOSENING, CYST, AND NECROSIS. MEDICAL RECORDS INDICATED: METALLOSIS; ABDUCTOR TENDON LOSS; AND ACETABULAR BONE LOSS; PROGRESSIVE LEFT HIP PAIN AND INABILITY TO DO DAILY ACTIVITIES; THERE WAS A LARGE DEFECT ON THE ANTERIOR ABDUCTOR REGION WHERE THERE WAS METALLIC DEBRIS; THERE WAS A DEFECT POSTERIORLY AND ONLY A THIN RIM OF ABDUCTOR TENDON; A LARGE AMOUNT OF METALLIC BLACK DEBRIS SURROUNDING THE REMNANTS OF THE CAPSULE; TAPER APPEARED TO BE IN GOOD CONDITION; THE ACETABULAR CUP WAS LOOSE AND EASILY REMOVED; THE ACETABULUM WAS CYSTIC WITH A LARGE AMOUNT OF INFERIOR AND MEDIAL BONE LOSS; DARK BLACK NECROTIC MATERIAL WAS REMOVED FROM THE CYSTIC AREAS AND IRRIGATED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260725 M2A-MAGNUM 42-50MM TPR INSRT-6 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 9990020

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R