BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD COMPONENT

    MDR report key: 8284928 · Received January 29, 2019

    Report

    Report Number
    0001825034-2019-00306
    Event Type
    Injury
    Date Received
    January 29, 2019
    Date of Event
    January 10, 2019
    Report Date
    April 22, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K993438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED YET REVIEW OF X-RAYS DEMONSTRATE A RIGHT TOTAL HIP ARTHROPLASTY WITH CEMENT FIXATION OF THE ACETABULAR CUP. ACETABULAR INCLINATION ANGLE ON THE NEUTRAL AP FILM MEASURES 60° (NORMAL IS 30-50°). SYMMETRIC POSITION OF THE FEMORAL HEAD WITHIN THE ACETABULAR CUP. SLIGHT VARUS POSITIONING OF THE FEMORAL STEM WITHIN THE FEMUR. NO SIGNIFICANT RADIOLUCENCY IS SEEN. SIGNS OF MALPOSITION WERE NOTED. DEVICE HISTORY RECORD 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 · 0

    IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY EIGHTEEN YEARS POST INITIAL SURGERY DUE TO HIP PAIN, BLOOD TOXICITY AND TRUNNIONOSIS DUE TO METAL FRAGMENTS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS- M2A-T M/H RAD SLD/APX SHL 62MM # ITEM 15-104062 LOT 831970, M2A TAPER 37/28MM LINER # ITEM 15-105000 LOT 929920, BI-METRIC POROUS FMRL 11X135MM # ITEM 162312 LOT 167040. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-00307. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MW5081860

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY EIGHT YEARS POST INITIAL SURGERY DUE TO HIP PAIN, BLOOD TOXICITY AND TRUNNIONOSIS DUE TO METAL FRAGMENTS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80581 M2A MODULAR HEAD COMPONENT PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 988080

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R