BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 52ODX46ID

    MDR report key: 6928798 · Received October 9, 2017

    Report

    Report Number
    0001825034-2017-08208
    Event Type
    Injury
    Date Received
    October 9, 2017
    Report Date
    December 15, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION: EXPIRATION DATE: JAN 31, 2019.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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.

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). 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. CONCOMITANT MEDICAL PRODUCTS: 157446, M2A-MAGNUM MOD HD, 122090; 14-103208, TAPERLOC MICROP FMRL 15.0 MM, 749840; 139254, M2A-MAGNUM 42-50 MM TPR INSRT-3, 482780. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-08209.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAS BEEN INDICATED FOR FUTURE REVISION DUE TO ASEPTIC LYMPHOCYTIC VASCULITIS ASSOCIATED LESION, PSEUDOTUMOR FORMATION, PAIN, AND ADVERSE REACTION TO METAL DEBRIS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711351 M2A-MAGNUM PF CUP 52ODX46ID PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 094380

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention