BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FMRL 9X137

    MDR report key: 3477470 · Received November 19, 2013

    Report

    Report Number
    0001825034-2013-05458
    Event Type
    Injury
    Date Received
    November 19, 2013
    Report Date
    January 26, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MEH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS" NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED." THIS REPORT IS NUMBER 6 OF 7 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-04085-1 AND 1825034-2013-05219 / -05222 AND -05458 / -05459).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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) 2008. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DYSFUNCTION, LOSS OF RANGE OF MOTION, ELEVATED BLOOD METAL IONS, METAL POISONING, AND METALLOSIS. SUBSEQUENTLY, LEGAL COUNSEL REPORTS PATIENT UNDERWENT A RIGHT REVISION PROCEDURE ON (B)(6) 2013. THE MODULAR HEAD, ACETABULAR CUP AND TAPER ADAPTER WERE REMOVED AND REPLACED. NO FURTHER REVISION PROCEDURES HAVE BEEN REPORTED 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 LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DYSFUNCTION, LOSS OF RANGE OF MOTION, ELEVATED BLOOD METAL IONS, METAL POISONING, AND METALLOSIS. SUBSEQUENTLY, LEGAL COUNSEL REPORTS PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE ON (B)(6) 2013. THE MODULAR HEAD, ACETABULAR CUP AND TAPER ADAPTER WERE REMOVED AND REPLACED. NO FURTHER REVISION PROCEDURES HAVE BEEN REPORTED TO DATE. ADDITIONAL INFORMATION RECEIVED FROM OPERATIVE REPORT NOTED A PSEUDOTUMOR, PAIN AND OSTEOLYSIS AROUND THE ACETABULAR CUP DURING THE LEFT HIP REVISION PROCEDURE ON (B)(6) 2013. OPERATIVE REPORT FURTHER NOTED PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2014 DUE TO SEROUS FLUID AND PAIN. THE MODULAR HEAD, ACETABULAR CUP AND TAPER ADAPTER WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599665 TAPERLOC POR FMRL 9X137 PROSTHESIS, HIP MEH BIOMET ORTHOPEDICS N/A 905290

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention