BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL E1 LINER 28MM A

    MDR report key: 13175720 · Received January 6, 2022

    Report

    Report Number
    0001825034-2022-00036
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Date of Event
    December 14, 2021
    Report Date
    January 28, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304526907
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER: 010000913 LOT NUMBER: 6903204 BRAND NAME: G7 HI-WALL E1 LINER, CATALOG NUMBER: 010000659 LOT NUMBER: 6950183 BRAND NAME: G7 PPS LTD ACET SHELL. MULTIPLE REPORTS WERE SUBMITTED ALONG WITH THIS REPORT: 0001825034-2022-00036, 0001825034-2022-00037. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED LINER FOUND SMALL SCRATCHES AND SCUFFS ON THE OUTER AND INNER DIAMETER. THE REMAINDER OF THE PROXIMAL RADIUS HAS TWO LARGE DIVOTS/GOUGES AND THE ANGLED WALL HAS A LINEAR CRACK THROUGH IT FROM SIDE TO SIDE WITH DAMAGE TO THE SCALLOPS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS 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 HIP ARTHROPLASTY, THE LINER WOULD NOT SEAT INTO THE SHELL CAUSING A 35 MINUTES DELAY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    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
    740145 G7 HI-WALL E1 LINER 28MM A PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 6903204 00880304526907

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female SEE H10 NARRATIVE