BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 52-60MM TPR INS STD

    MDR report key: 4781980 · Received May 19, 2015

    Report

    Report Number
    0001825034-2015-02092
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    March 12, 2012
    Report Date
    April 29, 2015
    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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "MATERIAL SENSITIVITY REACTIONS. IMPLANTATION OF FOREIGN MATERIAL IN TISSUES MAY RESULT IN HISTOLOGICAL REACTIONS INVOLVING VARIOUS SIZES OF MACROPHAGES AND FIBROBLASTS. THE CLINICAL SIGNIFICANCE OF THIS EFFECT IS UNCERTAIN, AS SIMILAR CHANGES MAY OCCUR AS A PRECURSOR TO OR DURING THE HEALING PROCESS. PARTICULATE WEAR DEBRIS AND DISCOLORATION FROM METALLIC AND POLYETHYLENE COMPONENTS OF JOINT IMPLANTS MAY BE PRESENT IN ADJACENT TISSUE OR FLUID. IT HAS BEEN REPORTED THAT WEAR DEBRIS MAY INITIATE A CELLULAR RESPONSE RESULTING IN OSTEOLYSIS OR OSTEOLYSIS MAY BE A RESULT OF LOOSENING OF THE IMPLANT." 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 8 MDRS FILED FOR THE SAME EVENT (1825034-2014-03219 & 1825034-2015-02091 & 02092 & 02093 & 02094 & 02095 & 02096 & 02097).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, LOOSENING, TISSUE NECROSIS AND ELEVATED METAL ION LEVELS. PATIENT'S LEGAL COUNSEL REPORTS A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. 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 NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2012 DUE TO PAIN AND POSSIBLE ADVERSE TISSUE REACTION TO METAL ON METAL IMPLANT. OPERATIVE REPORT FURTHER NOTED SEROSANGUINEOUS FLUID, LARGE PSEUDOTUMOR THAT WAS MULTILOCULATED, SOFT TISSUE REACTION, SCRATCHES ON THE FEMORAL HEAD AND ACETABULAR CUP, AND A RING OF CORROSION ON TAPER ADAPTER AND FEMORAL HEAD WERE FOUND. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED WITH A CERAMIC HEAD AND AN ACTIVE ARTICULATION POLYETHYLENE LINER WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT MEDICAL RECORDS INDICATE THAT PATIENT UNDERWENT AN INITIAL LEFT HIP ARTHROPLASTY ON AN UNKNOWN DATE IN (B)(6) 2005. SUBSEQUENTLY, PATIENT WAS REVISED ON THE LEFT HIP DUE TO INFECTION IN (B)(6) 2007 AND HAD ANTIBIOTIC SPACERS PUT IN. REVISION OPERATIVE REPORT NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2010 DUE TO RECURRENT DISLOCATION AND INSTABILITY. DURING THE REVISION, ANTERIOR OSTEOPHYTES ON THE ANTERIOR COLUMN WERE FOUND. THE MODULAR HEAD, ACETABULAR CUP, AND TAPER ADAPTER WERE REMOVED AND REPLACED AND AN ACETABULAR LINER WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT'S REVISION OPERATIVE REPORT NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2011 DUE TO INFECTION AND PATIENTS REPORT OF PAIN. DURING THE REVISION, PURULENT FLUID AND EXTENSIVE INFECTED GRANULATION TISSUE WERE FOUND. THE MODULAR HEAD, FEMORAL STEM, ACETABULAR LINER, AND ACETABULAR CUP WERE REMOVED. AN ACETABULAR CUP, OSS STEM, OSS TAPER ADAPTER, AND MODULAR HEAD WERE IMPLANTED. A REVISION OPERATIVE REPORT FROM (B)(6) 2011 NOTED PATIENT UNDERWENT A LEFT HIP REVISION DUE TO PERIPROSTHETIC FRACTURE AND SUSPECTED INFECTION. DURING THE REVISION, THE FRACTURE AT THE JUNCTION OF THE PROXIMAL AND MIDDLE THIRD FEMUR WAS FOUND. THE ACETABULAR CUP, OSS STEM, OSS TAPER ADAPTER, AND MODULAR HEAD WERE REMOVED AND AN ACETABULAR CUP AND LINER, MODULAR HEAD, AND AN OSS FEMORAL STEM WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325523 M2A-MAGNUM 52-60MM TPR INS STD PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 004150

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R