BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 52-60MM TPR INSRT-6

    MDR report key: 3953980 · Received July 23, 2014

    Report

    Report Number
    0001825034-2014-06416
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    March 6, 2014
    Report Date
    November 24, 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
    MO, 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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "FRETTING AND CREVICE CORROSION MAY OCCUR AT INTERFACES BETWEEN COMPONENTS." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 6 OF 6 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-04336 /-04337 /-04338 /-04339 /-06415 /-06416).

    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. THIS REPORT IS NUMBER 6 OF 8 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-04336 / 04339, 06415 / 06416 AND 08889 / 08890).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN, ELEVATED METAL ION LEVELS, PSEUDOTUMORS, FLUID, AND SOFT TISSUE NECROSIS. THERE HAS BEEN NO REPORTED LEFT HIP REVISION TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2014 DUE TO PAIN, ELEVATED METAL ION LEVELS, A PSEUDOTUMOR AND SUBLUXATION. OPERATIVE REPORT NOTED THE PRESENCE OF A PSEUDOTUMOR, MURKY BROWNISH YELLOW CLOUDY FLUID, NECROSIS, METAL DEBRIS, IMPINGEMENT ON THE FEMORAL NECK AND CUP, NOTCHED FEMORAL NECK, CUP OVER ANTEVERTED, SYNOVITIS, SOFT TISSUE REACTION, TAPER ADAPTER COLD-WELDED ONTO THE STEM, AND METAL STAINING. ALL COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR¿S COMPONENTS.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN, ELEVATED METAL ION LEVELS, PSEUDOTUMORS, FLUID, AND SOFT TISSUE NECROSIS. THERE HAS BEEN NO REPORTED LEFT HIP REVISION TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2014 DUE TO PAIN, ELEVATED METAL ION LEVELS, A PSEUDOTUMOR AND SUBLUXATION. OPERATIVE REPORT NOTED THE PRESENCE OF A PSEUDOTUMOR, MURKY BROWNISH YELLOW CLOUDY FLUID, NECROSIS, METAL DEBRIS, IMPINGEMENT ON THE FEMORAL NECK AND CUP, NOTCHED FEMORAL NECK, CUP OVER ANTEVERTED, SYNOVITIS, SOFT TISSUE REACTION, TAPER ADAPTER COLD-WELDED ONTO THE STEM, AND METAL STAINING. ALL COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR'S COMPONENTS. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEALED A LEFT HIP REVISION ON (B)(6) 2014 DUE TO PAIN, METAL-ON-METAL SOFT TISSUE REACTION, AND ELEVATED METAL ION LEVELS. THE PATIENT'S OPERATIVE REPORT NOTED BROWNISH YELLOW FLUID, HEAD/ADAPTER WAS COLD WELDED ONTO THE STEM, A CRACK IN THE GREATER TROCHANTER, AND SPLINTERING AND FRAGMENTATION OF BONE. ALL COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR'S COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431361 M2A-MAGNUM 52-60MM TPR INSRT-6 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 875150

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R