BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 3091689 · Received May 3, 2013

    Report

    Report Number
    0001825034-2013-01246
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 25, 2012
    Report Date
    February 6, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    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. 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." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01244/ 01249).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY FURTHER PATIENT INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 3 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01244/ 01249).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT UNDERWENT A LEFT REVISION ON (B)(6) 2011 AND A RIGHT REVISION ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF METALLOSIS AND OTHER UNKNOWN MEDICAL SYMPTOMS AND CONDITIONS. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. 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

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6), 2007 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6), 2009. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT UNDERWENT A LEFT REVISION ON (B)(6), 2011 AND A RIGHT REVISION ON (B)(6), 2012 DUE TO PATIENT ALLEGATIONS OF METALLOSIS AND OTHER UNKNOWN MEDICAL SYMPTOMS AND CONDITIONS. ADDITIONAL INFORMATION PROVIDED FROM LEGAL COUNSEL WITH OPERATIVE NOTES ON LEFT HIP INDICATES STERILE APPEARING FLUID, COTTAGE CHEESE APPEARING METALLOSIS REACTIVE TISSUE, METALLOSIS DEBRIS, FRETTING, PITTING AND WEAR, HYPERTROPHIC CAPSULE, A FRACTURE AND SOFT TISSUE DESTRUCTION AT TIME OF LEFT HIP REVISION. FURTHER INFORMATION WITH OPERATIVE NOTES ON THE RIGHT HIP INDICATE CLEAR FLUID CONSISTENT WITH ALVAL REACTION, COTTAGE CHEESE APPEARING MATERIAL CONSISTENT WITH ALVAL REACTION, HYPERTROPIC CAPSULE AND METALLOSIS REACTION AT TIME OF RIGHT HIP REVISION. ADDITIONAL INFORMATION FROM LEGAL COUNSEL WITH OPERATIVE NOTES INDICATE PATIENT'S BLOOD TEST RESULTS FOR CHROMIUM AND COBALT WERE ELEVATED AT TIME OF LEFT HIP REVISION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF铠COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195073 M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 001040

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R