BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL ARCOMXL LNR 36MM E

    MDR report key: 6751348 · Received July 28, 2017

    Report

    Report Number
    0001825034-2017-05224
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    June 27, 2017
    Report Date
    April 2, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS SIGNS OF MULTIPLE DAMAGES DUE TO IMPACTION OF THE LINER. DHR WAS REVIEWED AND NO DISCREPANCIES OR ANOMALIES WERE FOUND. ROOT CAUSE CANNOT BE IDENTIFIED WITH THE INFORMATION PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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

    THE ADDITIONAL INFORMATION CONTAINED WITHIN THIS REPORT HAVE NO EFFECT ON PREVIOUS INVESTIGATION CONCLUSION. 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)(6). CONCOMITANT PRODUCTS PART: 110017103 NAME: G7 FINNED 3 HOLE SHELL 52E LOT: 6038560, PART: 010000818 NAME: G7 HI-WALL ARCOMXL LNR 36MM E LOT: 6040048, PART: 010000998 NAME: G7 SCREW 6.5MM X 25MM LOT: 6058674. THE INVESTIGATION IS STILL IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATE REPORTS:0001825034-2017-05218, 0001825034-2017-05222, 0001825034-2017-05223.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGEON HAD A DIFFICULT TIME INSERTING THE LINER INTO THE CUP. HE USED A 32 BALL IMPACTOR AND HIT HARD TOWARD THE APEX OF THE CUP. HE TRIED SEVERAL TIMES, HITTING VERY HARD, BUT AN EDGE STAYED PROUD. HE REMOVED THE SCREW AND TRIED AGAIN WITH NO SUCCESS. THE SURGEON DECIDED TO SCRAP THE LINER AND TRY A NEW ONE. NO SUCCESS. HE THEN DECIDED TO REMOVE THE CUP AND INSERTED A RINGLOC PLUS SHELL. THE LINER WAS SEATED SUCCESSFULLY AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531642 G7 HI-WALL ARCOMXL LNR 36MM E PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 6040048

    Patients

    Seq Age Sex Outcome Treatment
    1 Other