BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARI-ANGLE HIP SYSTEM LAG SCREW 12.7X85 W/COMPRESSION SCREW

    MDR report key: 3953681 · Received July 23, 2014

    Report

    Report Number
    0001825034-2014-06419
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 26, 2014
    Report Date
    August 20, 2014
    Manufacturer
    BIOMET TRAUMA
    Product Code
    KTT
    PMA / PMN Number
    PK964880
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. IMPLANT DATE - UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY INITIAL PROCEDURE DATE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. IT IS LIKELY THE IMPLANT WAS OVERLOADED PRIOR TO PROPER HEALING OF THE BONE WHICH LED TO THE DEVICE FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP FIXATION PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENT RADIOGRAPHS TAKEN REVEALED THE LAG SCREW WAS FRACTURED. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014, TO REMOVE THE FRACTURED SCREW AND IMPLANT A BI-POLAR HIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP FIXATION PROCEDURE ON (B)(6) 2014. SUBSEQUENT RADIOGRAPHS TAKEN REVEALED THE LAG SCREW WAS FRACTURED. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014, TO REMOVE THE FRACTURED SCREW AND IMPLANT A BI-POLAR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430458 VARI-ANGLE HIP SYSTEM LAG SCREW 12.7X85 W/COMPRESSION SCREW APPLIANCE, FIXATION KTT BIOMET TRAUMA N/A 113460

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention