BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 15728479 · Received November 4, 2022

    Report

    Report Number
    0001822565-2022-03126
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    February 26, 2020
    Report Date
    December 19, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN-UNKNOWN BIOMET MAGNUM CUP SIZE 52-UNKNOWN. (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2022 - 02477. REPORTED EVENT WAS CONFIRMED VIA MEDICAL RECORDS PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT 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. DEVICE LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 2916596-2022-13104-1 . D10: US157852-M2A-MAGNUM PF CUP 52ODX46ID-163480, 11-104110-MLRY-HD POR FMRL 10X155MM-804030, 139256-M2A-MAGNUM 42-50 TPR INSRT STD-221910. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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

    IT WAS REPORTED PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 10 YEARS POST IMPLANTATION DUE TO METALLOSIS. DURING REVISION, DYSVASCULAR TISSUE IN THE HIP JOINT WAS RESECTED. THE FEMORAL HEAD WAS REPLACED WITH A DUAL MOBILITY 46MM BIPOLAR TYPE HEAD WITHOUT DIFFICULTY. THERE WERE NO COMPLICATIONS, AND THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509977 M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 405240

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10 NARRATIVE.| SEE H10 NARRATIVE.