BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL ARCOM LINER

    MDR report key: 7369214 · Received March 26, 2018

    Report

    Report Number
    0001825034-2018-02159
    Event Type
    Malfunction
    Date Received
    March 26, 2018
    Date of Event
    February 27, 2018
    Report Date
    June 14, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 00-6250-065-35, ITEM NAME: TRILOGY BONE SCREW, LOT NUMBER: UNKNOWN, ITEM NUMBER: 00-7850-012-00, ITEM NAME: VERYSYS ADVOCATE STEM, LOT NUMBER: UNKNOWN, ITEM NUMBER: 00-8018-036-03, ITEM NAME: VERSYS FEMORAL HEAD, LOT NUMBER: UNKNOWN, ITEM NUMBER: 010000663, ITEM NAME: G7 ACETABULAR SHELL, LOT NUMBER: UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED VIA VISUAL INSPECTION. VISUAL INSPECTION SHOWED DEFORMATION TO THE SCALLOPS AROUND THE LINER, ALSO THERE WERE TWO INDENTATIONS ON THE OUTSIDE RADIUS OF THE LINER. COMPLAINT DESCRIPTION SUGGEST THAT THE SCREW WAS FULLY SEATED PRIOR TO INSERTING THE LINER; HOWEVER THERE ARE INDENTATION MARKS ON THE OUTER SURFACE OF THE LINER LIKELY FROM THE LINER IMPINGING AGAINST THE SCREW. 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 · 1

    IT WAS REPORTED THAT THE LINER WOULD NOT SEAT WITH THE CUP DURING AN INITIAL HIP REPLACEMENT. ANOTHER DEVICE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212852 G7 HI-WALL ARCOM LINER PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 6115479

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR