BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCR 6.5X20 SELF-TAP

    MDR report key: 15215807 · Received August 12, 2022

    Report

    Report Number
    0001822565-2022-02359
    Event Type
    Injury
    Date Received
    August 12, 2022
    Date of Event
    July 5, 2022
    Report Date
    September 29, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024119802
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110010264, G7 SHELL, 7164631. 30103605, G7 VIT E LINER, 65055858. 00877503603, BIOLOX CERAMIC HEAD, 3061317. REPORT SOURCE JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2022 - 02360, 0001822565 - 2022 - 02361, 0001822565 - 2022 - 02362.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE SCREWS WERE NOT RETURNED AND PICTURES WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE LOOSE SCREWS. 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 PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 2 WEEKS POST IMPLANTATION DUE TO THE CUP COMPONENT BEING UNSTABLE. DURING THE SURGERY, THE STEM WAS REMOVED IN ORDER TO WIDEN THE OPERATIVE FIELD AND FOUND TO APPEAR GRAY RATHER THAN WHITE AND SUSPECTED THE COATING WAS PEELING OFF. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    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
    1689450 BONE SCR 6.5X20 SELF-TAP PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A J7161138 00889024119802

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H