BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASULA CONSTRAINED INSERT SIZE 38MM/65MM

    MDR report key: 10395483 · Received August 12, 2020

    Report

    Report Number
    0001822565-2020-02890
    Event Type
    Injury
    Date Received
    August 12, 2020
    Date of Event
    July 31, 2017
    Report Date
    October 15, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    K030923
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS WERE REVIEWED AND IDENTIFY THAT THE PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO LOOSENING, DISLOCATION, AND THIRD BODY WEAR. NOTED LOSS OF ABDUCTORS, GLUTEUS MEDIAS AND MINIMUS, AND LOSS OF GREATER TROCHANTER TO CONTRIBUTE TO INSTABILITY. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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). CONCOMITANT MEDICAL PRODUCTS: 01.01012.387 DURASUL COCR HD 38/+4 2335654. 11377004 CONSTRAINING RING 61044287. 7354-02-207 SCHAFT NH M/KRAGEN 12/14 7 R 1192728. 4360-00-065 HEMIS POR SHELL W/SEALED 1367353. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY TEN YEARS POST IMPLANTATION ON DUE TO PAIN AND IMPLANT FAILURE. THE PATIENT WAS REVISED AGAIN ON TWENTY YEARS LATER DUE TO DISLOCATION AND RECURRENT INSTABILITY. A THIRD REVISION WAS PERFORMED TWENTY SEVEN YEARS POST INITIAL SURGERY DUE TO DISPLACEMENT OF THE RIGHT HIP PROSTHESIS. HEAD AND LINER WERE REMOVED AND REPLACED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863524 DURASULA CONSTRAINED INSERT SIZE 38MM/65MM PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. N/A 61229951

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R