BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX54MM

    MDR report key: 6805401 · Received August 18, 2017

    Report

    Report Number
    0001825034-2017-06371
    Event Type
    Injury
    Date Received
    August 18, 2017
    Date of Event
    September 25, 2012
    Report Date
    February 21, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 15-105054 M2A 1 PC SHELL 38MMX54MM 043790, 11-173665 M2A 38MM MOD HD+9MM NK NO SKRT 568320, X11-180308 BI-METRIC/X POR NC LAT 8X120 144910. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED OP NOTES, WHICH NOTED A MINOR AMOUNT OF SYNOVIAL IRRITATION, AND A LARGE PROJECTION OF BONE ANTERIOR ASPECT OF THE ACETABULAR, WHICH WAS BELIEVED TO BE A SIGNIFICANT CAUSE OF PAIN. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN THE ASSOCIATED RISK DOCUMENTATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: PART: X11-180308 NAME: BI-METRIC/X POR NC LAT LOT:144910. THE INVESTIGATION IS STILL IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS:0001825034-2017-06372.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS INDICATED FOR A RIGHT HIP REVISION PROCEDURE DUE TO PERSISTENT GROIN PAIN AS WELL AS POSSIBLE ADVERSE TISSUE REACTION DUE TO ELEVATED METAL ION LEVELS. THE FEMORAL HEAD AND ACETABULAR COMPONENT WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO GROIN PAIN, ELEVATED METAL ION LEVELS, OSTEOLYSIS, AND ADVERSE REACTION TO METAL DEBRIS. IT WAS NOTED THAT THERE WERE SOME SYNOVIAL IRRITATION UPON ENTERING THE JOINT CAPSULE. THERE WAS ALSO A LARGE BONE PROJECTION OVER THE ANTERIOR ASPECT OF THE CUP. WHILE ATTEMPTING TO REMOVE THE OSETEOME A PORTION OF THE ANTERIOR SHELL CAME WITH IT. THEREFORE, THE CUP WAS REMOVED. NO COMPLICATIONS INDICATED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585256 M2A 1 PC SHELL 38MMX54MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 043790

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R