BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRAL/X POROUS RED PROX 9MM STEM

    MDR report key: 3140796 · Received May 31, 2013

    Report

    Report Number
    0001825034-2013-01749
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    June 21, 2012
    Report Date
    October 28, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK042029
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    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. 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." AND "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-01746 / 01749). 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 REPORTED THAT THE PATIENT UNDERWENT RIGHT M2A HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, A REVISION WAS PERFORMED (B)(6) 2012 DUE TO ALLEGED PAIN, DISCOMFORT, DYSFUNCTION, LOSS OF RANGE OF MOTION AND METALLOSIS. 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 THE REVISION THAT TOOK PLACE ON (B)(6) 2012 WAS DUE PAIN AND VERTICAL POSITION OF THE ACETABULAR CUP. OPERATIVE NOTES INDICATE PRESENCE OF BLACK-GRAY METALLIC-STAINED SYNOVIUM AND GRAYISH-GREEN, TURBID JOINT FLUID CONSISTENT WITH METALLOSIS. CORROSION AT THE TAPER ADAPTOR AND TRUNNION WAS NOTED. THE CUP, HEAD, AND TAPER ADAPTOR WERE REMOVED AND REPLACED WITH COMPETITOR COMPONENTS.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT RIGHT M2A HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, AN ALLEGED REVISION WAS PERFORMED (B)(6) 2012 DUE TO ALLEGED PAIN, DISCOMFORT, DYSFUNCTION, LOSS OF RANGE OF MOTION AND METALLOSIS. 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
    242004 INTEGRAL/X POROUS RED PROX 9MM STEM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 189530

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R