BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 50MM

    MDR report key: 11170727 · Received January 14, 2021

    Report

    Report Number
    0001825034-2021-00078
    Event Type
    Injury
    Date Received
    January 14, 2021
    Date of Event
    December 28, 2020
    Report Date
    May 18, 2021
    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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

      D10: ITEM NUMBER 11-103204 ITEM NAME TAPERLOC POR FMRL LAT 10X140 LOT # 906780 ITEM NUMBER 139254 ITEM NAME M2A-MAGNUM 42-50MM TPRINSRT-3 LOT # 312640 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED DEVIATIONS OR ANOMALIES DURING MANUFACTURING, THE DEVIATIONS OR ANOMALIES WOULD NOT HAVE ATTRIBUTED TO THE EVENT. MEDICAL RECORDS WERE NOT 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.   MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-01275.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: ITEM NUMBER US157856 ITEM NAME M2A-MAGNUM PF CUP 56ODX50ID LOT # 815320; ITEM NUMBER 11-103204 ITEM NAME TAPERLOC POR FMRL LAT 10X140 LOT # 906780. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS DUE TO HOSPITAL POLICY; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 00077.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT WAS REVISED 12 YEARS LATER DUE TO PAIN. METALLOSIS WAS FOUND DURING THE REVISION BUT NOT ENOUGH TO TAKE THE STEM. THE HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED WITH ACTIVE ARTICULATION DEVICES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69883 M2A-MAGNUM MOD HD SZ 50MM PROSTHETIC, HIP KWA ZIMMER BIOMET, INC. N/A 233960

    Patients

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