BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HD STD

    MDR report key: 4242322 · Received November 11, 2014

    Report

    Report Number
    0001825034-2014-08598
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 27, 2011
    Report Date
    November 3, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 8 STATES, ¿DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS.¿ NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿ NUMBER 15 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-06660 / 06661 AND 08598 AND 08600).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, DAMAGE TO BONE/TISSUE, LACK OF MOBILITY, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2011. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATES AND INDICATES THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT¿S MEDICAL RECORDS REVEALED REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011. THE PATIENT¿S OPERATIVE REPORT NOTED SCAR TISSUE, LOOSE ACETABULAR CUP, LATERAL OSTEOPHYTE, AND HETEROTOPIC OSSIFICATION. FURTHER INFORMATION IN PATIENT¿S MEDICAL RECORDS REVEALED A SECOND REVISION PROCEDURE PERFORMED ON (B)(6) 2011 DUE TO DISLOCATIONS. THE PATIENT¿S OPERATIVE REPORT FURTHER NOTED FIBROSIS, SCAR TISSUE, METALLOSIS WITHIN SOFT TISSUES, AND WEAR OF THE FEMORAL HEAD AT TIME OF REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726607 36MM COCR MOD HD STD PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 787240

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R