BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERTEK II PLUS HP ONLY

    MDR report key: 3790699 · Received May 5, 2014

    Report

    Report Number
    0001825034-2014-03503
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    October 21, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRX
    PMA / PMN Number
    PK020761
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN.

    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 AND TO CORRECT INFORMATION THAT WAS REPORTED IN ERROR ON THE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS FORWARDED TO THE SUPPLIER MANUFACTURER FOR EVALUATION. DURING THE EVALUATION, IT WAS NOTED THE COMPONENT HAD A MOTOR FAILURE. CAPA (B)(4) HAS BEEN INITIATED FOR DESIGN IMPROVEMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ACL LIGAMENT REPAIR PROCEDURE UTILIZING AN ENDOSCOPIC PUMP ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SCREEN OF THE PUMP DISPLAYED AN ERROR MESSAGE AND THE MOTOR STUTTERED. A DIFFERENT BIOMET ENDOSCOPIC PUMP WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY GREATER THAN THIRTY MINUTES TO THE PROCEDURE AS A RESULT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ACL LIGAMENT REPAIR PROCEDURE UTILIZING AN ENDOSCOPIC PUMP IN (B)(6) 2014. DURING THE PROCEDURE, THE SCREEN OF THE PUMP DISPLAYED AN ERROR MESSAGE AND THE MOTOR STUTTERED. A DIFFERENT BIOMET ENDOSCOPIC PUMP WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY GREATER THAN THIRTY MINUTES TO THE PROCEDURE AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267444 POWERTEK II PLUS HP ONLY PROSTHESIS, KNEE HRX BIOMET ORTHOPEDICS N/A 71494

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R