BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECIMED OFFSET ACETABULAR REA

    MDR report key: 10626288 · Received October 5, 2020

    Report

    Report Number
    0001825034-2020-03681
    Event Type
    Malfunction
    Date Received
    October 5, 2020
    Date of Event
    September 11, 2020
    Report Date
    December 16, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON REVIEW, IT WAS DETERMINED THAT WE DO NOT HAVE REPORTING RESPONSIBILITY FOR THIS HIP SYSTEM. THE INITIAL REPORT WAS SUBMITTED IN ERROR RAND SHOULD BE VOIDED. 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

    UPON REVIEW, IT WAS DETERMINED THAT WE DO NOT HAVE REPORTING RESPONSIBILITY FOR THIS HIP SYSTEM. THE INITIAL REPORT WAS SUBMITTED IN ERROR RAND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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 DURING AN INITIAL HIP PROCEDURE THE REAMER HANDLE FRACTURED WHILE REAMING THE ACETABULUM. THERE WAS NO DELAY IN PROCEDURE OR ADVERSE EVENT. SURGEON USED BACKUP REAMER TO COMPLETE PROCEDURE. 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
    1089685 PRECIMED OFFSET ACETABULAR REA PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 2485667-55

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR