BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL E1 LINER 36MM F

    MDR report key: 16672946 · Received April 4, 2023

    Report

    Report Number
    0001825034-2023-00743
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    February 28, 2023
    Report Date
    June 27, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    0099004527119
    PMA / PMN Number
    K121874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-00742, 0001825034-2023-00744. CAT #: 010000665 / G7 PPS LTD ACET SHELL 56F / LOT #: 7006364, CAT #: 010000858 / G7 NEUTRAL E1 LINER 36MM F / LOT #: 7151613. REPORT SOURCE: CHINA. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE LINER WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND PITTING ON THE OUTER RADIUS OF THE SHELL. IN THE SAME GENERAL LOCATION, TOOL MARKS WERE OBSERVED SIDEWALL AND THE BARB IS LIGHTLY ROUGHENED. SCRATCHING IS PRESENT ON THE OPPOSITE SIDE OF THE LINER'S OUTER RADIUS. THE COMPLAINT IS CONFIRMED BASED ON THE RETURNED DEVICE. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT 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

    IT WAS REPORTED ,THAT DURING AN INITIAL PROCEDURE, THE LINER DID NOT MATCH THE CUP PROPERLY. A NEW LINER WAS OPENED AND THE SECOND LINER ALSO DID NOT MATCH CORRECTLY WITH THE CUP. THERE WERE NO HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404397 G7 HI-WALL E1 LINER 36MM F PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. NI 6999247 0099004527119

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female