BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 10 DEG ARCOMXL LINER 32MM D

    MDR report key: 8425023 · Received March 15, 2019

    Report

    Report Number
    0001825034-2019-01179
    Event Type
    Injury
    Date Received
    March 15, 2019
    Date of Event
    December 5, 2015
    Report Date
    April 3, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K121874 
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS : HYPERION PROX PT STD BM CCD 50 PN:99A722.05B LN: 2015021830. REPORTED EVENT WAS CONFIRMED BY REVIEW OF REVISION OP NOTE WHICH NOTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION AND PERIPROSTHETIC FRACTURE. 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

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TWO WEEKS POST-IMPLANTATION DUE TO DISLOCATION. IT WAS FARTHER REPORTED THAT PATIENT UNDERWENT AN UNSUCCESSFUL CLOSED REDUCTION PROCEDURE PRIOR TO REVISION. OPERATIVE REPORTS RECEIVED NOTED FEMORAL LOOSENING AND A PERIPROSTHETIC FRACTURE WERE FOUND DURING THE REVISION PROCEDURE. A LARGE AND POINTED EXOSTOSIS AROUND THE MINOR TROCHANTER WAS ALSO NOTED. THE ACETABULAR LINER AND FEMORAL COMPONENTS WERE REMOVED AND REPLACE.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE- (B)(6). ASSOCIATED PRODUCT: DELTA CER FM HD 032/+4MM 12/14, 650-0835, LN 2015080069; G7 PPS LTD ACET SHELL 50D, PN: 010000662, LN: 3654474; HYPRN STEM CN DPHYS FIX 16X160, PN: 99A750.64, LN: 2014052093. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE 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 PATIENT UNDERWENT A REVISION PROCEDURE ONE MONTH POST-IMPLANTATION DUE TO DISLOCATION. 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
    217801 G7 10 DEG ARCOMXL LINER 32MM D PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 3199692

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R