BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 56MM

    MDR report key: 8066480 · Received November 13, 2018

    Report

    Report Number
    0001825034-2018-10423
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    October 16, 2017
    Report Date
    December 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.  SURGICAL NOTES DATED (B)(6) 2017 STATED THAT PATIENT UNDERWENT A LEFT HIP REVISION AS THERE WAS A CONCERN FOR METAL ALLERGY DUE TO METAL-ON-METAL ARTICULATION. UPON ENTERING THE HIP JOINT, BENIGN - APPEARING SYNOVIAL FLUID WAS OBTAINED AND WAS CULTURED. THERE WAS A SMALL ANTERIOR POCKET WHICH WAS REMOVED, CONSISTENT WITH A SMALL ANTERIOR CYSTIC LESION. THE HEAD WAS REVISED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.  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 UNDERWENT REVISION SURGERY AS THERE WAS A CONCERN FOR METAL ALLERGY DUE TO METAL-ON-METAL ARTICULATION APPROXIMATELY SEVEN YEARS POST INITIAL SURGERY. UPON ENTERING THE HIP JOINT, BENIGN APPEARING SYNOVIAL FLUID WAS OBTAINED AND WAS CULTURED. NO ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: CATALOG NUMBER: US157862 LOT NUMBER: 498290 BRAND NAME:M2A-MAGNUM PF CUP; CATALOG NUMBER: 192015 LOT NUMBER: 953610 BRAND NAME:ECHO POR FMRL NC ;CATALOG NUMBER: 139272 LOT NUMBER: 012030 BRAND NAME:M2A-MAGNUM 52-60MM TPR INSR. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.  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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO SEVERE PAIN APPROXIMATELY SEVEN YEARS POST INITIAL SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903317 M2A-MAGNUM MOD HD SZ 56MM PROSTHESIS. HIP KWA ZIMMER BIOMET, INC. N/A 548880

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R