BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 54ODX48ID

    MDR report key: 8922863 · Received August 22, 2019

    Report

    Report Number
    0001825034-2019-03761
    Event Type
    Injury
    Date Received
    August 22, 2019
    Report Date
    August 28, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES STATING THAT PRIOR TO THE REVISION IN FEB OF 2017, PATIENT UNDERWENT ANOTHER REVISION FOR INFECTION. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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). EVENT DATE SOMETIME BETWEEN (B)(6) 2016 AND (B)(6) 2017. EXPLANT DATE SOMETIME BETWEEN (B)(6) 2016 AND (B)(6) 2017. CONCOMITANT MEDICAL PRODUCTS: 163666 ¿ COCR MODULAR HEAD ¿ 243760; EP-200154 ¿ E1 ACTIVE ARTICULATION BEARING ¿ 783280; 11-104110 ¿ MALLORY HEAD FEMORAL STEM ¿ 625610; THERAPY DATE: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED FOR THE INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-03755, 0001825034-2019-03756, 0001825034-2019-03759.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT 2 REVISION SURGERIES APPROXIMATELY 6 YEARS POST IMPLANTATION. SUBSEQUENTLY, THE PATIENT UNDERWENT A THIRD REVISION DUE TO INFECTION. 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
    714336 M2A-MAGNUM PF CUP 54ODX48ID PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 424700

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R