BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SZ 56MM

    MDR report key: 4182238 · Received October 17, 2014

    Report

    Report Number
    0001825034-2014-08157
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    June 18, 2014
    Report Date
    August 24, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. (B)(4). NOT RETURNED BY ATTORNEY.

    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

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORD SHOWS 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 10 STATES, "FRETTING AND CREVICE CORROSION MAY OCCUR AT INTERFACES BETWEEN COMPONENTS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO ALLEGED PAIN, SQUEAKING, ELEVATED METAL ION LEVELS, AND FLUID COLLECTION. REVISION OPERATIVE REPORT NOTES PRESENCE OF A FLUID COLLECTION, METAL DEBRIS, AND CORROSION AT THE HEAD/NECK JUNCTION. THE CUP WAS NOTED TO BE STABLE AND 2 DEGREES TO THE VERTICAL. THE CUP REMAINS IMPLANTED; THE HEAD WAS REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO ALLEGED PAIN, SQUEAKING, ELEVATED METAL ION LEVELS, AND FLUID COLLECTION. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT PATIENT ALLEGEDLY EXPERIENCED DISCOMFORT, LACK OF MOBILITY, SORENESS, PAIN, BONE FRACTURE, DISLOCATION, WEAR AND METALLOSIS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITION INFORMATION RECEIVED IN REVISION OPERATIVE REPORT NOTES PRESENCE OF A FLUID COLLECTION, METAL DEBRIS, AND CORROSION AT THE HEAD/NECK JUNCTION. THE CUP WAS NOTED TO BE STABLE AND 2 DEGREES TO THE VERTICAL. THE CUP REMAINS IMPLANTED; THE HEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661645 M2A-MAGNUM MODULAR HEAD SZ 56MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 899580

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R