BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 56ODX50ID

    MDR report key: 8061461 · Received November 12, 2018

    Report

    Report Number
    0001825034-2018-10447
    Event Type
    Injury
    Date Received
    November 12, 2018
    Date of Event
    June 26, 2017
    Report Date
    December 4, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: ITEM# 157450, M2A-MAGNUM MOD HD SZ 50MM, LOT# 837870. ITEM# 139256, M2A-MAGNUM 42-50 TPR INSRT STD, LOT# 890980. ITEM# 11-104113, MLRY-HD POR FMRL 13X170MM, LOT# 101520. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES WHICH INDICATED MRI FINDINGS IDENTIFIED LARGE SIZE PSEUDOTUMOR CONSISTENT WITH ADVERSE LOCAL TISSUE REACTION TO THE METAL ON METAL COMPONENTS, WHICH WAS THE SOURCE OF PAIN. MEASUREMENT OF LEG LENGTHS PRIOR TO PROCEDURE IDENTIFIED THAT PATIENT'S LEFT LEG WAS SLIGHTLY LONGER THAN THE RIGHT IN SUPINE POSITION. DURING THE PROCEDURE, LARGE AMOUNT OF CLOUDY YELLOW FLUID WAS FOUND AND SENT FOR GRAM STAIN AND CULTURE WHICH SHOWED NUMEROUS WHITE BLOOD CELLS BUT NO ORGANISMS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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 PATIENT UNDERWENT A REVISION 7 YEARS POST INITIAL IMPLANTATION DUE TO PAIN, ADVERSE TISSUE REACTION, AND PSEUDOTUMOR. MEASUREMENT OF LEG LENGTHS PRIOR TO PROCEDURE IDENTIFIED THAT PATIENT'S LEFT LEG WAS SLIGHTLY LONGER THAN THE RIGHT IN SUPINE POSITION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT(S): 0001825034 - 2018 - 10446; 0001825034 - 2018 - 10447; 0001825034 - 2018 - 10449. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902248 M2A-MAGNUM PF CUP 56ODX50ID PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 373980

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNK PART LOT, CUP, STEM, HEAD