BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX58MM CUP

    MDR report key: 14675937 · Received June 13, 2022

    Report

    Report Number
    0001825034-2022-01387
    Event Type
    Injury
    Date Received
    June 13, 2022
    Date of Event
    January 13, 2015
    Report Date
    July 19, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT PRODUCTS: CATALOG NUMBER: 11-103209 LOT NUMBER:119590 BRAND NAME: TAPERLOC FEMORAL STEM . CATALOG NUMBER:RD118858 LOT NUMBER: 912800 BRAND NAME: M2A 38 MM CUP. CATALOG NUMBER:11-173663 LOT NUMBER:000400 BRAND NAME:M2A HEAD. MULTIPLE REPORTS WERE SUBMITTED ALONG WITH THIS REPORT 0001825034-2022-01387, 0001825034-2015-01287. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES. RIGHT SIDE FINDINGS: PATIENT HISTORY PAIN, AND ELEVATED COBALT AND CHROMIUM LEVELS AS REPORTED. NO INTEROP COMPLICATIONS WERE NOTED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ROOT CAUSE COULD NOT 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 DUE TO DUE TO PAIN AND ELEVATED COBALT AND CHROMIUM LEVELS APPROXIMATELY 11 YEARS POST IMPLANTATION. CORROSION AND OSTEOLYSIS WERE NOTED DURING THE PROCEDURE. MEDICAL RECORDS INDICATED THAT THERE WAS A LARGE GREEN TINGE STAINED TROCHANTER BURSA FILLED WITH 20ML OF CLEAR JOINT FLUID UPON ENTERING THE JOINT DURING THE REVISION PROCEDURE. THERE WAS ALSO MINIMAL PROLIFERATIVE SYNOVITIS, NO PSEUDOTUMOR, NO OSTEOLYSIS, THE TRUNNION WAS NOTED TO BE CLEAN WITHOUT EVIDENCE OF TRUNNIONOSIS, AND THE FEMORAL STEM AND CUP WERE BOTH VERY SECURELY OSTEOINTEGRATED. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1490062 M2A 38MMX58MM CUP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 912800

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention| H SEE H10 NARRATIVE