BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FEMORAL LAT 10X140

    MDR report key: 2973011 · Received February 21, 2013

    Report

    Report Number
    0001825034-2013-00317
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    March 8, 2010
    Report Date
    April 13, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY." NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00316 / 00317).

    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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY AND REPORTS AND THAT A REVISION PROCEDURE OCCURRED IN 2010 DUE TO PATIENT ALLEGATIONS OF PAIN AND LOOSENING. ADDITIONAL INFORMATION PROVIDED IN A REVIEW OF INVOICE HISTORY CONFIRMS THE HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2008; HOWEVER, A REVISION INVOICE WAS NOT LOCATED. NO FURTHER INFORMATION HAS BEEN PROVIDED 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 THE PATIENT ALLEGES THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY AND REPORTS AND THAT A REVISION PROCEDURE OCCURRED IN 2010 DUE TO PATIENT ALLEGATIONS OF PAIN AND LOOSENING. ADDITIONAL INFORMATION PROVIDED IN A REVIEW OF INVOICE HISTORY CONFIRMS THE HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2008; HOWEVER, A REVISION INVOICE WAS NOT LOCATED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE OPERATIVE REPORT NOTED PATIENT UNDERWENT A LEFT HIP ARTHROPLASTY ON (B)(6) 2008 AND A RIGHT HIP ARTHROPLASTY ON (B)(6) 2004. OPERATIVE REPORT FURTHER NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2010 DUE TO LOOSENING. OPERATIVE REPORT NOTED THE PRESENCE OF LOOSENING OF THE CUP AND STEM, METAL DEBRIS AND DARK COLORATION OF THE TISSUE. ALL COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR COMPONENTS. NO REVISION PROCEDURE HAS BEEN REPORT FOR THE RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76451 TAPERLOC POR FEMORAL LAT 10X140 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 068170

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R