BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 TYPE1 PPS HO 13.0

    MDR report key: 3751897 · Received April 15, 2014

    Report

    Report Number
    0001825034-2014-02798
    Event Type
    Injury
    Date Received
    April 15, 2014
    Date of Event
    September 25, 2012
    Report Date
    July 14, 2014
    Manufacturer
    BIOMET U.K. LTD
    Product Code
    KWA
    PMA / PMN Number
    PK101086
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "LOOSENING OR MIGRATION OF IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY. "

    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 (ASSOCIATED) DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 14 STATES, ¿POSTOPERATIVE BONE FRACTURE AND PAIN" THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-02796 / 02798).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2012, AND A REVISION PROCEDURE ON (B)(6) 2012, DUE TO PATIENT ALLEGATIONS OF PAIN AND TISSUE AND BONE DESTRUCTION. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE. AN INVOICE COULD NOT BE LOCATED TO CONFIRM THE REVISION SURGERY DATE OR WHICH COMPONENTS WERE REMOVED AND REPLACED DURING THE REVISION PROCEDURE. 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 THAT PATIENT UNDERWENT TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2012, AND A REVISION PROCEDURE ON (B)(6) 2012, DUE TO PATIENT ALLEGATIONS OF PAIN AND TISSUE AND BONE DESTRUCTION. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE. AN INVOICE COULD NOT BE LOCATED TO CONFIRM THE REVISION SURGERY DATE OR WHICH COMPONENTS WERE REMOVED AND REPLACED DURING THE REVISION PROCEDURE. 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 LEFT HIP REVISION ON (B)(6) 2012 DUE TO DEFORMITY OF THE ACETABULAR SHELL AND FAILURE OF INGROWTH. OPERATIVE REPORT NOTED THE PRESENCE OF SYNOVIAL FLUID, LOOSE STEM, FIBROUS TISSUE, CHRONIC SYNOVITIS AND A NONDISPLACED PELVIC DISCONTINUITY WITH A T-TYPE PATTERN. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A COMPETITOR'S COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229215 TPRLC 133 TYPE1 PPS HO 13.0 PROSTHESIS, HIP KWA BIOMET U.K. LTD N/A 2368579

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R