BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 4621612 · Received March 20, 2015

    Report

    Report Number
    0001825034-2015-01119
    Event Type
    Injury
    Date Received
    March 20, 2015
    Date of Event
    March 18, 2004
    Report Date
    March 4, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK991807
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 RELATED TO THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: BRAND NAME - TI LOW PROFILE SCREW 6.5X35MM: CATALOG NUMBER ¿ 103534, LOT NUMBER - 110780, EXPIRATION DATE ¿ SEPTEMBER 30, 2011, MANUFACTURE DATE ¿ SEPTEMBER 12, 2001. OR THE PART/LOT INFORMATION COULD BE: BRAND NAME - TI LOW PROFILE SCREW 6.5X25MM: CATALOG NUMBER - 103532, LOT NUMBER ¿ 087370, EXPIRATION DATE ¿ AUGUST 31, 2011, MANUFACTURE DATE ¿ AUGUST 27, 200. OR THE PART/LOT INFORMATION COULD BE: BRAND NAME - TI LOW PROFILE SCREW 6.5X40MM: CATALOG NUMBER - 103535, LOT NUMBER - 228550, EXPIRATION DATE ¿ FEBRUARY 28, 2010, MANUFACTURE DATE ¿ MARCH 02, 2000. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: " FATIGUE FRACTURE OF COMPONENT MAY OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 7 OF 7 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05344 / 05348 & 2015-01118 /-01119).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2001 AND LEFT HIP REVISION PROCEDURES ON (B)(6) 2004 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, ELEVATED METAL ION LEVELS, METAL POISONING AND METALLOSIS. A REVIEW OF INVOICE HISTORY REVEALED PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY ON (B)(6) 2005. THERE HAS BEEN NO REPORTED RIGHT HIP REVISION PROCEDURE TO DATE. 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 REVISION ON (B)(6) 2004 DUE TO PROTRUSIO OF THE CUP WITH OSTEOLYSIS AND SCREW BREAKAGE. OPERATIVE REPORT FURTHER NOTED THE PRESENCE OF METALLOSIS, FLUID, LOOSE ACETABULAR CUP, 2 BROKEN SCREWS, 1 REMAINING SCREW WAS GROUND OFF, DEFECT ON THE ACETABULUM RIM, AND NO SIGNS OF INFECTION. THE MODULAR HEAD, ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED. OPERATIVE REPORT FURTHER NOTED PATIENT UNDERWENT A SECOND LEFT HIP REVISION ON (B)(6) 2004 DUE TO DISLOCATION. OPERATIVE REPORT FURTHER NOTED THE PRESENCE OF HYPERTROPHIC SYNOVIUM AND MEMBRANOUS TISSUE. THE ACETABULAR CUP WAS WELL FIXED. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED. OPERATIVE REPORT FURTHER NOTED THE PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY ON (B)(6) 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190870 UNKNOWN SCREW PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R