BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 HI-WALL ARCOM XL LINER

    MDR report key: 7040412 · Received November 17, 2017

    Report

    Report Number
    0001825034-2017-10177
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    October 9, 2017
    Report Date
    February 7, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTED: UDI #. CONCOMITANT MEDICAL PRODUCTS: G7 FINNED 4 HOLE SHELL, CATALOG#: 110017105, LOT#: 6057872; TAPERLOC FEMORAL, CATALOG#: 51-101110, LOT#: 3743645; BIOLOX MODULAR HEAD, CATALOG#: 12-115122, LOT#: 2887338; RINGLOC + ACETABULAR DRILL BIT, CATALOG#: 31-323230, LOT#: 970150. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE LINER FOUND MULTIPLE FORMS OF DAMAGE. THE RIM OF THE LINER IS GOUGED. A SMALL SCRATCH/GOUGE WAS OBSERVED ON THE OUTER RADIUS. THE SIDE WALL AND SCALLOPS ALSO SHOWED SIGNS OF GOUGING. THE BARB IS DEFORMED IN MULTIPLE AREAS. A MATERIAL HAIR WAS ALSO FOUND TO BE PROTRUDING FROM THE BARB. ALL FORMS OF DAMAGE OBSERVED APPEAR TO BE FROM ATTEMPTS TO IMPACT AND REMOVE THE LINER. NO DIMENSIONAL ANALYSIS WILL BE COMPLETED DUE TO THE LINER BEING IMPACTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. 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 THE SURGEON COULD NOT FULLY SEAT THE LINER DURING IMPLANTATION. SURGERY WAS DELAYED 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821950 G7 HI-WALL ARCOM XL LINER PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6109297

    Patients

    Seq Age Sex Outcome Treatment
    1