BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 10 DEG ARCOMXL LINER

    MDR report key: 9007165 · Received September 12, 2019

    Report

    Report Number
    0001825034-2019-03928
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    July 24, 2019
    Report Date
    December 27, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI: (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF ONE G7 10 DEG ARCOMXL LINER 36MM F WHICH WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE LINER HAS BEEN DAMAGED. THE LOCKING FEATURE IS MISSING IN TWO LOCATIONS AROUND THE LINER AND THE SCALLOPS SHOW DAMAGE COMPLETELY AROUND THE LINER. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). G7 10 DEG ARCOMXL LINER 36MM F, PN 010000780, LN 6329035, G7 PPS LTD ACET SHELL 56F, PN 010000665, LN 6335983, CER BIOLOXD OPTION HD 36MM, PN 650-1057, LN 2982638, CER OPT TYPE 1 TPR SLEVE 0MM, PN 650-1066, LN 2955122, UNKNOWN STEM, PN UNKNOWN, LN UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-03929. CUSTOMER HAS INDICATED THAT THE PRODUCT HAS BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT SUFFERED A MINOR FALL. THE PATIENT WAS THEN REVISED APPROXIMATELY ONE MONTH AFTER THE INITIAL SURGERY, DUE TO THE LINER DISASSOCIATING FROM THE CUP. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809239 G7 10 DEG ARCOMXL LINER PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6329035

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R