BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 42A

    MDR report key: 12163006 · Received July 13, 2021

    Report

    Report Number
    0001825034-2021-02057
    Event Type
    Injury
    Date Received
    July 13, 2021
    Date of Event
    June 21, 2021
    Report Date
    October 13, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ONE G7 NEUTRAL E1 LINER 28MM AND ONE G7 PPS LTD ACET SHELL 42A WERE RETURNED AND EVALUATED. UPON VISUAL INSPECTION THERE ARE THREE CIRCULAR INDENTATIONS ON THE OD OF THE LINER THAT MATCH UP TO THE LOCATION OF THE THREE HOLES IN THE SHELL. THE LINER FITS INTO THE SHELL HOWEVER THEY WERE NOT PRESSED TOGETHER TO SEE IF THEY WOULD LOCK INTO PLACE. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED DEVIATIONS OR ANOMALIES DURING MANUFACTURING, THE DEVIATIONS OR ANOMALIES WOULD NOT HAVE ATTRIBUTED TO THE EVENT. ROOT CAUSE COULD NOT 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). REPORT SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER:010000835, LOT NUMBER: 6822743, BRAND NAME: G7 NEUTRAL E1 LINER. MULTIPLE REPORTS WERE SUBMITTED ALONG WITH THIS REPORT 0001825034-2021-02056. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY THE LINER WOULD NOT ASSEMBLE WITH THE CUP WHICH LED TO A DELAY IN SURGERY BY 35 MINUTES AND PATIENT BLOOD LOSS OF 900 ML. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054142 G7 PPS LTD ACET SHELL 42A PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 6736706

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other