BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FMRL 12.5X145

    MDR report key: 3882869 · Received June 19, 2014

    Report

    Report Number
    0001825034-2014-05628
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    July 22, 2014
    Report Date
    June 1, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY." NUMBER 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05626 / 05628).

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 3 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034- 05626 / 05628 & 2015-01848 / 01849).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. LEGAL COUNSEL FOR PATIENT REPORTED PATIENT ALLEGATIONS OF IMPLANT LOOSENING, MIGRATION, METALLOSIS, PAIN, LIMP, TISSUE REACTION, DAMAGE TO SURROUNDING BONE AND TISSUE, AND LACK OF MOBILITY. THERE HAS BEEN NO REPORTED REVISION PROCEDURE 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

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. LEGAL COUNSEL FOR PATIENT REPORTED PATIENT ALLEGATIONS OF IMPLANT LOOSENING, MIGRATION, METALLOSIS, PAIN, LIMP, TISSUE REACTION, DAMAGE TO SURROUNDING BONE AND TISSUE, AND LACK OF MOBILITY. 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 INDICATES THAT PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2014 DUE TO A VERTICAL ACETABULAR CUP AND ELEVATED METAL ION LEVELS. REVISION OPERATIVE REPORT NOTED THE PRESENCE OF METAL DEBRIS, BLACK DISCOLORED TISSUE, AND BLACKISH COLORED FLUID. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A COMPETITOR ACETABULAR SYSTEM AND A BIOMET HEAD. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2014 DUE TO HIGH METAL IONS AND PAIN. REVISION OPERATIVE REPORT NOTED A SLIGHTLY VERTICAL ACETABULAR COMPONENT, BLACKISH DISCOLORATION OF TISSUE INSIDE THE JOINT, AND WEAR ON THE UNDERSURFACE OF THE HIP LEADING TO MORE DEBRIS. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A COMPETITOR ACETABULAR SYSTEM AND A BIOMET HEAD.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. LEGAL COUNSEL FOR PATIENT REPORTED PATIENT ALLEGATIONS OF IMPLANT LOOSENING, MIGRATION, METALLOSIS, PAIN, LIMP, TISSUE REACTION, DAMAGE TO SURROUNDING BONE AND TISSUE, AND LACK OF MOBILITY. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORT NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2014 DUE TO A VERTICAL ACETABULAR CUP AND ELEVATED METAL ION LEVELS. OPERATIVE REPORT NOTED THE PRESENCE OF METAL DEBRIS, BLACK DISCOLORED TISSUE, AND BLACKISH COLORED FLUID. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A COMPETITOR ACETABULAR SYSTEM AND A BIOMET HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361508 TAPERLOC POR FMRL 12.5X145 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 797080

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R