BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 42MM

    MDR report key: 9465628 · Received December 13, 2019

    Report

    Report Number
    0001825034-2019-05554
    Event Type
    Injury
    Date Received
    December 13, 2019
    Date of Event
    May 24, 2018
    Report Date
    March 11, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 11-103200 ¿ TAPERLOC FEMORAL STEM ¿ 964320. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING LEFT HIP PAIN AND METALLOSIS. CYSTIC CHANGES UNDER THE CUP COMPONENT SEEN WITH X-RAYS. LOOSENING OF THE IMPLANTS AND A LARGE DEFECT ON THE ANTERIOR ABDUCTOR REGION WHERE THERE WAS METALLIC DEBRIS. THERE IS 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 APPEARS TO BE IN GOOD CONDITION. 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. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: M2A-MAGNUM PF CUP 48ODX42ID PN US157848, LN 990820, M2A-MAGNUM 42-50MM TPR INSRT-6, PN 139252, LN 999020. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-05558, 0001825034-2019-05559. 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
    1260381 M2A-MAGNUM MOD HD SZ 42MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 024950

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R