BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 8969594 · Received September 6, 2019

    Report

    Report Number
    0001825034-2019-03960
    Event Type
    Injury
    Date Received
    September 6, 2019
    Report Date
    September 4, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: TRIFLANGE SHELL, PN: PM0002127, LN: 904360. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001822565-2019-02789. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF A RADIOGRAPH WAS PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: OVERALL FIT AND ALIGNMENT OF THE IMPLANTS IS APPROPRIATE. RIGHT THA WITH ACETABULAR RECONSTRUCTION AND LOOSENING OF THE INFERIOR MOST SCREW AND THE INFERIOR METAL PLATE IN THIS REGION AS WELL AS POSSIBLE LOOSE SCREW INFERIOR TO THE FEMORAL NECK AND OVERLYING THE GREATER TROCHANTER. NO CONTRIBUTING FACTORS ARE IDENTIFIED. 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 · 1

    IT WAS REPORTED DURING THE INITIAL PROCEDURE THAT THE TRIFLANGE CUP WOULD NOT SEAT PROPERLY. POST-INITIAL PROCEDURE, THE LOCKING SCREWS BACKED OUT OF THE CUP AS CONFIRMED BY RADIOGRAPHS. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. 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
    764269 UNKNOWN SCREW PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other