BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD STD NK

    MDR report key: 4213031 · Received October 30, 2014

    Report

    Report Number
    0001825034-2014-08417
    Event Type
    Injury
    Date Received
    October 30, 2014
    Report Date
    October 9, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    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 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." 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.¿ THIS REPORT IS NUMBER 6 OF 6 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01870 / 01872 AND 08415 / 08417).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(4) 2012 DUE TO ACETABULAR CUP LOOSENING AND BONE LOSS. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH BIOMET PRODUCT. PATIENT UNDERWENT ANOTHER REVISION PROCEDURE ON (B)(6) 2013 DUE TO ACETABULAR CUP LOOSENING AND SCREW FRACTURE. THE MODULAR HEAD, ACETABULAR CUP, LINER AND SCREWS WERE REMOVED AND REPLACED. BONE GRAFTING WAS ALSO DONE AND AN ACETABULAR CAGE WAS PLACED DURING THE REVISION PROCEDURE ON (B)(6) 2013. LEGAL COUNSEL FOR PATIENT ALLEGES PATIENT ALLEGATIONS OF PAIN, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, IMPAIRMENT, LACK OF MOBILITY, AND ELEVATED METAL ION LEVELS. ADDITIONAL INFORMATION RECEIVED NOTED PATIENT IS BILATERAL. PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEAL THE (B)(6) 2012 RIGHT HIP REVISION WAS DUE TO A LOOSE ACETABULAR COMPONENT. THE PATIENT¿S OPERATIVE REPORT NOTED MURKY FLUID, THE LOOSE ACETABULAR COMPONENT, OSTEOLYSIS, METAL DEBRIS, BONE/SOFT TISSUE STAINED WITH METALLIC DEBRIS, AND BONE LOSS. FURTHER INFORMATION IN PATIENT MEDICAL RECORDS REVEAL THE (B)(6) 2013 RIGHT HIP REVISION WAS DUE TO A LOOSE ACETABULAR COMPONENT. THE PATIENT¿S OPERATIVE REPORT NOTED BONE LOSS, THE LOOSE ACETABULAR COMPONENT WITH FRACTURED SCREW, AND DEBRIS; AND A BONE GRAFT AND ACETABULAR CAGE WAS PLACED. THERE HAS BEEN NO REPORTED REVISION PROCEDURE OF THE LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695738 M2A 38MM MOD HD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 757610

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization