BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 STR MONOBLOCK SHELL INSRTR

    MDR report key: 8915634 · Received August 21, 2019

    Report

    Report Number
    0001825034-2019-03724
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    July 11, 2019
    Report Date
    November 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI # (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE INSERTER. VISUAL INSPECTION FOUND IMPACT MARKS, DISCOLORATION, AND SCRATCHING ON THE SHAFT AND STRIKE PLATE OF THE INSERTER. THE DAMAGE IS CONSISTENT WITH A MULTIPLE USE INSTRUMENT. NO DAMAGE OR DEFORMATION WAS OBSERVED WHILE INSPECTING THE INSERTER THREADS. DEVICE HISTORY RECORD (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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: G7 OSSEOTI 3 HOLE SHELL 52MM E, PN: 110010244, LN: 6482864. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001825034-2019-03724. CUSTOMER HAS INDICATED THAT THE PRODUCT HAS BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 THAT A SHELL GOT STUCK ON THE INSERTER DURING IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710056 G7 STR MONOBLOCK SHELL INSRTR PROSTHESIS, HIP LXH ZIMMER BIOMET, INC. N/A 067100

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR