BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW

    MDR report key: 4633543 · Received March 25, 2015

    Report

    Report Number
    0001825034-2015-01203
    Event Type
    Injury
    Date Received
    March 25, 2015
    Date of Event
    April 27, 2008
    Report Date
    April 1, 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
    IN, 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, DEVICE CODE - KWA, CATALOG NUMBER ¿ 103534, LOT NUMBER - 515420, EXPIRATION DATE ¿ MAY 31, 2016, MANUFACTURE DATE ¿ MAY 19, 2006. OR THE PART/LOT INFORMATION COULD BE: BRAND NAME - TI LOW PROFILE SCREW 6.5X30MM, DEVICE CODE - KWA, CATALOG NUMBER ¿ 103533, LOT NUMBER - 584740, EXPIRATION DATE ¿ JUNE 30, 2016, MANUFACTURE DATE ¿ JUNE 5, 2006. OR THE PART/LOT INFORMATION COULD BE: BRAND NAME - TI LOW PROFILE SCREW 6.5X60MM, DEVICE CODE - KWA, CATALOG NUMBER ¿ 103538, LOT NUMBER - 869980, EXPIRATION DATE ¿ FEBRUARY 28, 2013, MANUFACTURE DATE ¿ FEBRUARY 21, 2003. OR THE PART/LOT INFORMATION COULD BE: BRAND NAME - TI LOW PROFILE SCREW 6.5X25MM, DEVICE CODE - KWA, CATALOG NUMBER - 103532, LOT NUMBER ¿ 739070, EXPIRATION DATE ¿ JUNE 30, 2016, MANUFACTURE DATE ¿ JUNE 22, 2006. 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 2 OF 2 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-05342 AND 2015-01203).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2008 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, AND ELEVATED METAL ION LEVELS. 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 TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE WITH UNKNOWN COMPONENTS. OPERATIVE NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2006 WHERE ALL COMPONENTS WERE REMOVED AND A BIOMET HIP WAS IMPLANTED. OPERATIVE REPORT FURTHER NOTED PATIENT UNDERWENT A SECOND LEFT HIP REVISION ON (B)(6) 2008. OPERATIVE REPORT NOTED THE PRESENCE OF CLEAR FLUID AND A BROKEN SCREW. THE BROKEN SCREW WAS REMOVED. THE MODULAR HEAD, LINER AND ACETABULAR CUP WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTED PATIENT WAS REVISED ON (B)(6) 2008 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE AND ELEVATED METAL ION LEVELS. ADDITIONAL INFORMATION RECEIVED NOTED THE PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2008 NOT (B)(6) 2008. 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 TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE WITH UNKNOWN COMPONENTS. OPERATIVE NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2014 WHERE ALL COMPONENTS WERE REMOVED AND A BIOMET HIP WAS IMPLANTED. OPERATIVE REPORT FURTHER NOTED PATIENT UNDERWENT A SECOND LEFT HIP REVISION ON (B)(6) 2008. OPERATIVE REPORT NOTED THE PRESENCE OF CLEAR FLUID AND A BROKEN SCREW. THE BROKEN SCREW WAS REMOVED. THE MODULAR HEAD, LINER AND ACETABULAR CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200531 TI LOW PROFILE SCREW PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R