BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPACTOR

    MDR report key: 17344391 · Received July 18, 2023

    Report

    Report Number
    0001825034-2023-01647
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    May 16, 2023
    Report Date
    July 17, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCT: 010000704 G7 BONEMASTER LTD ACET SHL 54F LOT NUMBER 7253370. REPORT SOURCE: SWITZERLAND. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. UNABLE TO CONFIRM COMPLAINT AS NO PRODUCT OR IMAGES WERE PROVIDED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-01646. 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. H3 OTHER TEXT : DEVICE LOCATION IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE G7 SHELL WAS HAMMERED IN, THE SURGEONS NOTICED THAT THE SCREW CONNECTION ON THE IMPACTOR HAD LOOSENED OR A SUSPENSION DEVELOPED AND THE FORCE COULD NOT BE TRANSMITTED. NO PATIENT IMPACT REPORTED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765716 UNKNOWN IMPACTOR INSTRUMENT, HIP LXH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose