BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW

    MDR report key: 4634783 · Received March 26, 2015

    Report

    Report Number
    0001825034-2015-01215
    Event Type
    Injury
    Date Received
    March 26, 2015
    Date of Event
    January 4, 2012
    Report Date
    March 6, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    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 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 6.5X30MM, DEVICE CODE - KWA, CATALOG NUMBER ¿ 103533, LOT NUMBER - 210240, EXPIRATION DATE ¿ MAY 31, 2018, MANUFACTURE DATE ¿ MAY 22, 2008. OR THE PART/LOT INFORMATION COULD BE: BRAND NAME - TI LOW PROFILE SCREW 6.5X25MM, DEVICE CODE - KWA, CATALOG NUMBER - 103532, LOT NUMBER ¿ 511940, EXPIRATION DATE ¿ MARCH 31, 2018, MANUFACTURE DATE ¿ MARCH 4, 2008. OR THE PART/LOT INFORMATION COULD BE: BRAND NAME - TI LOW PROFILE SCREW 6.5X30MM, DEVICE CODE - KWA, CATALOG NUMBER ¿ 103533, LOT NUMBER - 706450, EXPIRATION DATE ¿ SEPTEMBER 30, 2017, MANUFACTURE DATE ¿ SEPTEMBER 28, 2007. 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 3 OF 3 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-07763 AND 2015-01214 /-01215).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, DYSFUNCTION, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS, METALLOSIS, METAL POISONING, AND LACK OF MOBILITY. 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 RIGHT HIP REVISION ON (B)(6) 2012, DUE TO PAIN, DIFFICULTY WALKING, LOOSE ACETABULAR CUP AND BROKEN SCREWS. OPERATIVE REPORT NOTED THE PRESENCE OF SCAR TISSUE, FLUID, BROKEN SCREWS, FIBRINOUS TISSUE, 1 BROKEN SCREW REMAINED IMPLANTED, LOSS OF ACETABULAR WALL ANTERIOR SUPERIOR, AND FIBROUS INGROWTH ON CUP. THE MODULAR HEAD, ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED WITH A COMPETITOR CUP AND BIOMET HEAD AND TAPER ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203638 TI LOW PROFILE SCREW PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R