BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 7947199 · Received October 9, 2018

    Report

    Report Number
    0001825034-2018-09482
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    April 18, 2017
    Report Date
    August 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PAIN, DISCOMFORT, ELEVATED METAL IONS AND FAILED METAL-ON-METAL CONSTRUCT. LAB RESULTS SHOWED THAT PATIENT HAD ELEVATED METAL IONS : CO 15.2 MCG\L AND CR 13.9 MCG\L. DURING THE PROCEDURE THERE WAS SOFT TISSUE REACTION CONSISTENT WITH METALLOSIS. THERE WAS NO EVIDENCE OF LOOSENING AND THE COMPONENTS WERE INTACT. THE HEAD WAS REMOVED. A 46MM ACTIVE ARTICULATION BEARING WITH A 28MM INNER HEAD WERE USED TO COMPLETE THE PROCEDURE. PATIENT TOLERATED THE PROCEDURE WELL. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. THE RECEIVED ADDITIONAL INFORMATION DOES NOT CHANGE THE FINAL CONCLUSIONS OF PREVIOUS INVESTIGATIONS. 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO RELATED DEVIATIONS/ANOMALIES WERE IDENTIFIED THAT AFFECT THE REPORTED EVENT. A DEFINITIVE 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

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

    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: US157852 ¿ M2A MAGNUM CUP ¿ 230690. 166316 ¿ PROGRESSIVE FEMORAL STEM ¿ 68450. 139258 ¿ M2A MAGNUM TAPER INSERT ¿ 873420. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-09481.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY 9 YEARS POST IMPLANTATION DUE TO PAIN, ELEVATED METAL ION LEVELS, DISCOMFORT, INFLAMMATION, METALLOSIS, AND LOSS OF RANGE OF MOTION. 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
    788597 M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 414570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R