BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIGHT KNEE ANGULAR HINGE KIT

    MDR report key: 5347663 · Received January 6, 2016

    Report

    Report Number
    0001825034-2016-00067
    Event Type
    Injury
    Date Received
    January 6, 2016
    Date of Event
    December 9, 2015
    Report Date
    March 15, 2016
    Manufacturer
    BIOMET TRAUMA
    Product Code
    KTT
    PMA / PMN Number
    PK953406
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. EVALUATION FOUND RETURNED PRODUCT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. A CONCLUSIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION AND TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. LOT NUMBER - THE LOT NUMBER COULD BE 696720 OR 864170.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2015. DURING THE PROCEDURE, THE RIGHT EX FIX WAS JAMMED, AND THE HINGE WAS UNABLE TO BE DISTRACTED. A 30 MINUTE DELAY IN PROCEDURE RESULTED, AS A LEFT EX FIX DEVICE WAS USED TO FINISH THE PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2015. DURING THE PROCEDURE, THE RIGHT EXTERNAL FIXATION DEVICE WAS JAMMED, AND THE HINGE WAS UNABLE TO BE DISTRACTED. A 30 MINUTE DELAY IN PROCEDURE RESULTED, AS A LEFT EXTERNAL FIXATION DEVICE WAS USED TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6892 RIGHT KNEE ANGULAR HINGE KIT APPLIANCE, FIXATION KTT BIOMET TRAUMA N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R