BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 FRDM CONST E1 10DEG LNR 36F

    MDR report key: 13018394 · Received December 16, 2021

    Report

    Report Number
    0001825034-2021-03333
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    November 22, 2021
    Report Date
    January 21, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    0088030454458
    PMA / PMN Number
    K142882
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED: LOT 7012746, VISUAL INSPECTION FOUND THE BARB TO BE FLATTENED AND DEFORMED IN MULTIPLE LOCATIONS. DEFORMATION WAS ALSO OBSERVED ON THE SIDE WALL OF THE LINER. THE OUTER RADIUS OF THE LINER IS SCRATCHED AND INDENTED. SCRATCHING WAS ALSO OBSERVED ON THE RIM. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110010283-G7 FRDM CONST E1 10DEG LNR 36F-7012750; 010000665- G7 PPS LTD ACET SHELL 56F-UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 03334. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SURGEON TRIED SEATING THE G7 FREEDOM SIZE F LINER INTO THE CUP WITHOUT SUCCESS. SURGEON OPENED ANOTHER G7 FREEDOM SIZE F LINER AND TRIED SEATING THE CUP WITH THE SAME RESULTS. AFTER TWO WASTED LINERS, A NEUTRAL FREEDOM WAS OPENED AND SEATED WITH FIRST MALLET BLOW. 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
    1917371 G7 FRDM CONST E1 10DEG LNR 36F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 7012746 0088030454458

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown