BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 56ODX50ID

    MDR report key: 6813848 · Received August 23, 2017

    Report

    Report Number
    0001825034-2017-06685
    Event Type
    Injury
    Date Received
    August 23, 2017
    Date of Event
    July 5, 2016
    Report Date
    December 15, 2020
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PATIENT WEIGHT OVER (B)(6) LBS. CONCOMITANT MEDICAL PRODUCTS: PART: 157450, M2A-MAGNUM MOD HD SZ 50MM, LOT: 838780. PART: US157856, M2A-MAGNUM PF CUP 56ODX50ID, LOT: 892130. PART: 11-103206, TAPERLOC POR LAT FMRL 12.5X145, LOT: 369700. PART: 139256, M2A-MAGNUM 42-50 TPR INSRT STD, LOT: 092670.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ONE M2A-MAGNUM MOD HD SZ 50MM AND ONE M2A-MAGNUM PF CUP 56ODX50ID WERE RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE HEAD TAPER HAS A BLACK LINE AROUND THE INSIDE AND DAMAGE TO THE FACE OF THE DEVICE. THE OUTSIDE RADIUS HAS SOME SCUFFING AND A DULL SPOT TO THE FINISH. THE CUP HAS SCUFFING TO THE INSIDE RADIUS AND THERE IS DEBRIS ON THE OUTSIDE RADIUS. ADDITIONAL INFORMATION DOES NOT CHANGE THE ROOT CAUSE OF THE PREVIOUS INVESTIGATION. 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 · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY A CORRECTION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AN UPDATED INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS AND LAB RESULTS NOTING PRE-REVISION ION LEVELS TO BE ELEVATED VERSUS A DECREASE IN LEVELS POST-REVISION. ADDITIONAL INFORMATION DOES NOT CHANGE THE ROOT CAUSE OF THE PREVIOUS INVESTIGATION. 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 · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NUMBER CORRESPONDING TO THIS MEDWATCH IS (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE ITEM AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE COULD NOT 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

    PATIENT WAS REVISED NINE YEARS POST INITIAL IMPLANTATION DUE TO ELEVATED METAL IONS, PAIN, AND RATCHETING IN THE HIP. DURING THE REVISION PROCEDURE, METALLOSIS APPEARING FLUID WAS EVACUATED FROM THE JOINT SPACE. THE ACETABULAR SHELL AND FEMORAL HEAD WERE REPLACED WITHOUT COMPLICATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE; HOWEVER, NONE WAS AVAILABLE.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 1

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED APPROXIMATELY NINE YEARS POST-IMPLANTATION DUE TO DISCOMFORT, AUDIBLE NOISE AND ELEVATED ION LEVELS.THE SURGEON NOTED RIGHT HIP WEAR OF JOINT SURFACE, WITH ASSOCIATED SYMPTOMS OF RATCHETING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594511 M2A-MAGNUM PF CUP 56ODX50ID PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 892130

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNKNOWN HEAD