BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX48MM

    MDR report key: 8019278 · Received October 30, 2018

    Report

    Report Number
    0001825034-2018-09973
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    April 16, 2018
    Report Date
    June 4, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 USE OF A 38 MM BIOLOX DELTA HEAD IN A M2A 38 MM CUP IS NOT AN APPROVED COMBINATION, HOWEVER, THIS PATIENT WAS PART OF A MHRA APPROVED STUDY WHEN IMPLANTED WITH THE DEVICES IN 2009. THE INTENT OF THAT STUDY WAS TO INVESTIGATE THE USE OF THIS HEAD AND CUP IN THIS CONFIGURATION. 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.

    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). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 12-115131, CER BIOLOXD MOD HD 38MM -3, LOT # 1620268; ITEM # 162030, BI-METRIC HAP 10X130 MM, LOT # 1470803. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY 9 YEARS POST IMPLANTATION DUE TO METAL REACTION CAUSING OSTEOLYSIS AFFECTING POSTERIOR WALL AND RIM OF SOCKET. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858740 M2A 1 PC SHELL 38MMX48MM HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 660120

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R