BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-3

    MDR report key: 3221175 · Received July 11, 2013

    Report

    Report Number
    0001825034-2013-02623
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    March 5, 2013
    Report Date
    October 28, 2013
    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

    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 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 3 OF 5 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-02621 / 02625). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY PROCEDURES AND REPORTS ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, METALLOSIS, TISSUE/BONE DESTRUCTION, LACK OF MOBILITY, DISCOMFORT AND DIFFICULTY WALKING. REVIEW OF INVOICE HISTORY CONFIRMS TOTAL HIP ARTHROPLASTY PROCEDURES OCCURRED ON LEFT SIDE (B)(6) 2008 AND RIGHT SIDE (B)(6) 2009. REVIEW OF INVOICE HISTORY CONFIRMS REVISION PROCEDURES WERE PERFORMED ON LEFT SIDE (B)(6) 2010, AND RIGHT SIDE (B)(6) 2013. THE HEADS AND TAPER ADAPTERS WERE REMOVED AND REPLACED. REVIEW OF INVOICE HISTORY ADDITIONALLY FOUND A REVISION PROCEDURE PERFORMED ON (B)(6) 2010, ON UNKNOWN SIDE DUE TO UNKNOWN REASON. THIS COMPLAINT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY PROCEDURES AND REPORTS ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, METALLOSIS, TISSUE/BONE DESTRUCTION, LACK OF MOBILITY, DISCOMFORT AND DIFFICULTY WALKING. REVIEW OF INVOICE HISTORY CONFIRMS TOTAL HIP ARTHROPLASTY PROCEDURES OCCURRED ON LEFT SIDE (B)(6) 2008 AND RIGHT SIDE (B)(6) 2009. REVIEW OF INVOICE HISTORY CONFIRMS REVISION PROCEDURES WERE PERFORMED ON (B)(6) AND ON (B)(6) 2010. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES THAT LEFT HIP REVISION OPERATIVE REPORT DATED (B)(6) 2010 NOTES PRESENCE OF CLEAR FLUID, AN ANTEVERTED CUP, FIBROUS TISSUE, AND OTHER MATERIAL. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED WITH COMPETITOR ACETABULAR COMPONENTS AND A BIOMET HEAD. PATIENT'S MEDICAL RECORDS INDICATE THAT THE PROCEDURE THAT TOOK PLACE ON (B)(6)2010 WAS A FURTHER LEFT HIP REVISION. REVISION OPERATIVE REPORT DATED (B)(6) 2010 NOTES PRESENCE OF CLEAR FLUID. THE HEAD WAS REMOVED AND REPLACED. REVISION OPERATIVE REPORT FOR THE RIGHT HIP DATED (B)(6) 2013 NOTED THE PRESENCE OF CLEAR FLUID, TISSUE NECROSIS, AND NO CUP INGROWTH. THE MODULAR HEAD, ACETABULAR CUP, AND TAPER INSERT WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320114 M2A-MAGNUM 42-50MM TPR INSRT-3 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 788790

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R