BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A HI CARBON TAPER LINER

    MDR report key: 6772915 · Received August 7, 2017

    Report

    Report Number
    0001825034-2017-06004
    Event Type
    Injury
    Date Received
    August 7, 2017
    Date of Event
    April 7, 2008
    Report Date
    August 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    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 · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2017-06004, 0001825034-2017-06005, 0001825034-2017-06565. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS ¿ M2A NON-FLARED ONE-PIECE CUP P/N 15-106054 L/N 039820; MODULAR LATERALIZED TAPERLOC FEMORAL P/N 11-103204 P/N 735230; M2A MODULAR COMPONENT HEAD P/N 11-173662 L/N 743860. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2017-06004, 0001825034-2017-06005. CONCOMITANT MEDICAL PRODUCTS ¿ M2A HI CARBON TAPER LINER P/N 15-105011 L/N 234270; M2A HI CARBON MODULAR HEAD P/N 11-163677 L/N 050590M2A UNIVERSAL SHELL P/N 15-103648 L/N 994630; TI LOW PROFILE SCREW P/N 103536 L/N 263780; TI LOW PROFILE SCREW P/N 103533 L/N 752490 TAPERLOC FEMORAL P/N 11-103206 L/N 992660.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ON THE SAME DAY AS IMPLANTATION DUE TO DISLOCATION. AFTER THE PROCEDURE WHILE RECOVERING, IT WAS NOTED THAT THE PATIENT¿S HIP HAD DISLOCATED ANTERIORLY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552813 M2A HI CARBON TAPER LINER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 234270

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R