BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD +3MM NK

    MDR report key: 3230124 · Received July 16, 2013

    Report

    Report Number
    0001825034-2013-02719
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 17, 2013
    Report Date
    January 27, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    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 2 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN. NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02719 / 02720).

    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

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCES. EVIDENCE OF WEAR ON ARTICULAR SURFACE SUGGESTS POSSIBLE DISLOCATION OR SUBLUXATION OF THE HEAD OR FROM STEM IMPINGEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AUGUST 21, 2006. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO ELEVATED COCR LEVELS, TISSUE DAMAGE AND PAIN. THE CUP AND HEAD WERE REMOVED AND REPLACED WITH CUP, HEAD, AND A POLYETHYLENE LINER. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL LEFT HIP ARTHROPLASTY ON (B)(6), 2006. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2013 DUE TO ELEVATED COCR LEVELS, TISSUE DAMAGE AND PAIN. THE CUP AND HEAD WERE REMOVED AND REPLACED WITH A COMPETITOR'S CUP, A BIOMET HEAD, AND A BIOMET POLYETHYLENE LINER. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT'S LEGAL COUNSEL ALLEGES SORENESS, DISCOMFORT, DYSFUNCTION, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, METAL POISONING, METALLOSIS, LOSS OR RANGE OF MOTION AND MOBILITY. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REPORTS PATIENT'S LEFT LOWER EXTREMITY TO BE 1.5CM LONGER THAN HER RIGHT LOWER EXTREMITY PRIOR TO THE REVISION. DURING THE REVISION SURGERY, OPERATIVE NOTES REPORT A PSEUDO ABSCESS, A FLUID-FILLED BLACKENED CYST, METALLOSIS, AND BLACKENED TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329970 M2A 38MM MODULAR HEAD +3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 603530

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R