BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HD -3MM NK

    MDR report key: 3112427 · Received May 14, 2013

    Report

    Report Number
    0001825034-2013-01475
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    January 3, 2012
    Report Date
    April 15, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 6 OF 6 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-01470 / 01475). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE REASON FOR THE REVISION PROCEDURE, WHICH 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, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 6 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01470 / 01475).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGED THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2011, DUE TO ALLEGED PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LOOSENING, METALLOSIS, AND LACK OF MOBILITY. FURTHER REVISION WAS PERFORMED (B)(6) 2012 ALLEGEDLY DUE TO INFECTION. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2011, WAS DUE PAIN AND ELEVATED METAL ION LEVELS. THE OPERATIVE NOTES CONFIRM THAT THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. THE REVISION THAT TOOK PLACE ON (B)(6) 2012 WAS DUE TO INFECTION. THE OPERATIVE NOTES CONFIRM THAT THE MODULAR HEAD, LINER, ACETABULAR CUP AND FEMORAL STEM WERE REMOVED AND REPLACED WITH ANTIBIOTIC MOLDS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGED THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2011 DUE TO ALLEGED PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LOOSENING, METALLOSIS, AND LACK OF MOBILITY. A FURTHER REVISION WAS PERFORMED ON (B)(6) 2012 ALLEGEDLY DUE TO INFECTION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212635 28MM DIA COCR MOD HD -3MM NK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 094350

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R