BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW 6.5X40MM

    MDR report key: 3427768 · Received October 24, 2013

    Report

    Report Number
    0001825034-2013-04859
    Event Type
    Injury
    Date Received
    October 24, 2013
    Date of Event
    January 15, 2008
    Report Date
    September 24, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK991807
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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 2 STATES, ¿BENDING OR FRACTURE OF THE IMPLANT.¿ THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER - (B)(4), LOT NUMBER - 544240, EXPIRATION DATE ¿ DEC 31, 2013, MANUFACTURE DATE ¿ DEC 22, 2003. OR THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER - (B)(4), LOT NUMBER - 754090, EXPIRATION DATE ¿ FEB 28, 2014, MANUFACTURE DATE ¿ FEB 23, 2004. OR THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER - (B)(4), LOT NUMBER - 190050, EXPIRATION DATE ¿ OCT 31, 2013,. MANUFACTURE DATE ¿ OCT 20, 2003. OR THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER - (B)(4), LOT NUMBER - 775280, EXPIRATION DATE ¿ FEB 28, 2014, MANUFACTURE DATE ¿ FEB 23, 2004. OR THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER - (B)(4), LOT NUMBER - 332400, EXPIRATION DATE ¿ DEC 31, 2013, MANUFACTURE DATE ¿ DEC 4, 2003. OR THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER - (B)(4), LOT NUMBER - 161950, EXPIRATION DATE ¿ SEP 30, 2013, MANUFACTURE DATE ¿ SEP 26, 2003. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-04859/04860 AND 04862).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT REVISION HIP ARTHROPLASTY ON (B)(6) 2004, TO IMPLANT A BIOMET CONSTRAINED SYSTEM DUE TO UNKNOWN REASONS. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2008, DUE TO WEAR OF THE ACETABULAR COMPONENT AND THE PRESENCE OF OSTEOLYSIS. OPERATIVE NOTES STATE THERE WERE FRACTURED SCREWS PRESENT. IT IS UNKNOWN WHICH SCREW(S) WERE FRACTURED. THE CONSTRAINED HEAD, ACETABULAR COMPONENT AND POLYETHYLENE LINER WERE REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545790 TI LOW PROFILE SCREW 6.5X40MM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 544240

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R