BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM FEMORAL HEAD

    MDR report key: 7813098 · Received August 24, 2018

    Report

    Report Number
    0001825034-2018-08506
    Event Type
    Injury
    Date Received
    August 24, 2018
    Date of Event
    October 25, 2016
    Report Date
    August 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS : ITEM NUMBER: X21-180313, ITEM NAME:HA BIMETRIC/X POR NC STD 13MM, LOT #:461530, ITEM NUMBER: 15-105056 ITEM NAME: M2A 1 PC SHELL 38MMX56MM, LOT #: 970020. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-03211, 0001825034-2018-08507-2. 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. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. REPORTED EVENT WAS CONFIRMED BY OPERATIVE NOTES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND.ROOT CAUSE WAS UNABLE TO 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.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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 AS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 9 YEARS POST-IMPLANTATION DUE TO PAIN, ELEVATED ION LEVELS, METAL POISONING, METALLOSIS, MALPOSITION OF THE ACETABULAR SHELL, PEUDOTUMOR, PSEUDOCAPSULE, ADVERSE LOCAL TISSUE REACTION, SUBLUXATION, INSTABILITY, LIMB LENGTH DISCREPENCY AND CORROSION AROUND THE TRUNNION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 15-105056, ITEM NAME: M2A MAGNUM CUP, LOT #: 970020; ITEM NUMBER: X21-180313, ITEM NAME: BIMETRIC FEMORAL STEM, LOT #: 461530. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 08507. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT AS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 9 YEARS POST-IMPLANTATION DUE TO PAIN, ELEVATED ION LEVELS, METAL POISONING, METALLOSIS AND LIMITED RANGE OF MOTION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654767 M2A 38MM FEMORAL HEAD PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 049930

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R