BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 ARCOMXL LINER

    MDR report key: 7537074 · Received May 23, 2018

    Report

    Report Number
    0001825034-2018-03551
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    April 25, 2018
    Report Date
    September 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE LINER WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND TWO CIRCULAR INDENTATIONS IN THE OUTER RADIUS OF THE LINER. THE OUTER SIDE WALL AND SCALLOPS ARE ALSO SCRATCHED AND GOUGED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CONCOMITANT PRODUCT(S): A 010000660 G7 ACETABULAR SHELL 6122056; 010000658 G7 ACETABULAR SHELL 3930175; 010000913 G7 HI-WALL E1 LINER 6167725; 103530 TI PROFILE SCREW 2016040532; 103532 TI PROFILE SCREW 2015090213; 103533 TI PROFILE SCREW 2017011260; 130914 MULLER CUP 3753738; 00801802801 VERSYS FEMORAL HEAD 63920806; 0100561213 WAGNER TAPER STEM 2761649. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03547, 0001825034-2018-03550, 0001825034-2018-03552.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP ARTHROPLASTY THE POLYETHYLENE LINER WOULD NOT SEAT WITH THE ACETABULAR SHELL. THERE WAS AN ADDED DELAY OF ONE-TWO HOURS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378918 G7 ARCOMXL LINER PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6109148

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention