BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANSWER 9X125 COCR LAT

    MDR report key: 14250635 · Received April 29, 2022

    Report

    Report Number
    0001825034-2022-00992
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    August 13, 2019
    Report Date
    April 29, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDG
    UDI-DI
    00880304252660
    PMA / PMN Number
    K931194
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER: 11-173661 LOT NUMBER:036230 BRAND NAME: M2A 38MM MOD HD; CATALOG NUMBER:RD118848 LOT NUMBER:942430 BRAND NAME: M2A 38MMX48MM CUP; CATALOG NUMBER:162501 LOT NUMBER:170890 BRAND NAME: ANSWER 9X125 COCR LAT. MULTIPLE REPORTS WERE SUBMITTED ALONG WITH THIS REPORT 0001825034-2022-00678 AND 0001825034-2022-00679. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: FAILED RIGHT TOTAL HIP REPLACEMENT WITH SUSPECTED ALTR FROM METAL ON METAL BEARING. PSEUDO CAPSULE AND LYTIC INFLAMMATION ENCOUNTERED, GRAY STAINING OF SYNOVIAL LINING AND THICKENED YELLOW TAN TISSUE DEVELOPED AND DEBRIDED. CORROSION TO THE TRUNNION NOTED AND CLEANED. DEFECT BEHIND ACETABULUM INVOLVING POSTERIOR PORTION OF THE POSTERIOR COLUMN, CUP APPEARED TO BE WELL FIXED TO THE ILIUM. BLACK LYTIC MEMBRANE TISSUE DEBRIDED FROM THE HIP JOINT SPACE AND ALLOGRAFT BONE PLACED INTO DEFECT. NOTED BLACK MATERIAL TO GREATER TROCHANTER AND DEBRIDED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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 THE PATIENT WAS REVISED WITH SUSPICION OF ADVERSE LOCAL TISSUE REACTION APPROXIMATELY 15 YEARS POST IMPLANTATION. DURING THE REVISION THERE WAS A PSEUDO CAPSULE, CORROSION, LYTIC INFLAMMATION, GRAY STAINING, BLACK LYTIC MEMBRANE MATERIAL FOUND AND BONE DEFECT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100603 ANSWER 9X125 COCR LAT PROSTHESIS, HIP JDG ZIMMER BIOMET, INC. N/A 170890 00880304252660

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R