BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD COMPONENT 12/14 TAPER 38MM HEAD DIAMETER

    MDR report key: 6807307 · Received August 21, 2017

    Report

    Report Number
    0001825034-2017-06516
    Event Type
    Injury
    Date Received
    August 21, 2017
    Date of Event
    July 24, 2014
    Report Date
    September 29, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK043537
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO PRODUCT WAS RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD  (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE REPORTED COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED WITH INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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

    (B)(4). CONCOMITANT PRODUCTS: 15-105058 042460 M2A SPECIAL ACETABULAR CUP 38MM I.D. X 58 MM O.D. W/ RIM SCREW HOLES/POROUS COAT, UNKNOWN STEM. COUNTRY:(B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 06518.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT¿S LEFT HIP WAS REVISED APPROXIMATELY 8 YEARS POST-IMPLANTATION DUE TO ELEVATED METAL IONS, METALLOSIS, AND TUMOR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT¿S LEFT HIP WAS REVISED APPROXIMATELY 8 YEARS POST-IMPLANTATION DUE TO ELEVATED METAL IONS AND TUMOR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588925 M2A MODULAR HEAD COMPONENT 12/14 TAPER 38MM HEAD DIAMETER PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 545210

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE