BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL ARCOMXL LINER 36MM E

    MDR report key: 8867536 · Received August 6, 2019

    Report

    Report Number
    0001825034-2019-03450
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    July 1, 2019
    Report Date
    November 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI# (B)(4). IMPLANT DATE IS BLANK AS THIS PRODUCT WAS NEVER IMPLANTED. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL INSPECTION OF THE RETURNED LINER IDENTIFIED THERE WERE NO MARKINGS OR INDENTATIONS TO THE OUTSIDE RADIUS OF THE LINER. THERE WAS INDENTATION UNDER THE SCALLOPS LIKELY CAUSED DURING AN ATTEMPT TO IMPACT THE LINER WITH THE SHELL. DIMENSIONAL ANALYSIS OF THE LINER IDENTIFIED IT TO BE CONFORMING TO PRINT SPECIFICATIONS DURING MANUFACTURING. NO PEELING OF THE COATING WAS OBSERVED ON THE LINER. 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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). ITEM # 110017103 G7 FINNED 3 HOLE SHELL LOT # 6395058, ITEM # 51-104110 TAPERLOC STEM LOT # 6341460, ITEM #12-115121 CER BIOLOXD MOD HD LOT # 2971338. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2019 -03455.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PRIMARY LEFT TOTAL HIP ARTHROPLASTY (THA) SURGERY WAS PERFORMED. UPON ATTEMPTING TO SEAT THE LINER IT FAILED TO SEAT. AN ADDITIONAL ATTEMPT WAS MADE WITH THE SAME LINER, BUT IT AGAIN FAILED TO SEAT. A NEW LINER WAS REQUESTED AND IT WAS NOTED PLASTIC WAS NOTICED TO HAVE FLAKED OFF (PEELED AWAY) AT SOME SPOTS ON THE FIRST LINER. NOTHING FELL INTO THE SURGICAL WOUND. NO HARM OR INJURY TO PATIENT WAS NOTED. A NEW LINER WAS USED TO COMPLETE THE PROCEDURE AND WORKED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659803 G7 HI-WALL ARCOMXL LINER 36MM E PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. 6126575

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR