BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD COMPONENT 28 MM HEAD DIAMETER MINUS 6 MM NECK

    MDR report key: 5741603 · Received June 22, 2016

    Report

    Report Number
    0001825034-2016-02205
    Event Type
    Injury
    Date Received
    June 22, 2016
    Date of Event
    May 25, 2016
    Report Date
    October 5, 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
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-02205 / 02206).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL AND CORRECTED INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT MEDICAL PRODUCTS - BI-METRIC FEMORAL STEM CATALOG #: 162309, LOT #: 931300, MALLORY/HEAD ACETABULAR SHELL CATALOG #: 10-104050, LOT #: 957630, LOW PROFILE SCREW CATALOG #: 103631, LOT #: 303240.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY A ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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 INDICATED A HIP REVISION PROCEDURE MAY OCCUR TWELVE YEARS POST-IMPLANTATION DUE TO PAIN, INFECTION, AND ELEVATED METAL ION LEVELS; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TWELVE YEARS POST-IMPLANTATION DUE TO PAIN, INFECTION, AND ELEVATED METAL ION LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY TWELVE YEARS POST-IMPLANTATION DUE TO PAIN, INFECTION, AND ELEVATED METAL ION LEVELS. IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP ASPIRATION APPROXIMATELY TWELVE YEARS POST-IMPLANTATION. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397660 M2A MODULAR HEAD COMPONENT 28 MM HEAD DIAMETER MINUS 6 MM NECK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 293860

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention