BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HP FEM IMP/EXT

    MDR report key: 5288876 · Received December 11, 2015

    Report

    Report Number
    1818910-2015-37273
    Event Type
    Malfunction
    Date Received
    December 11, 2015
    Date of Event
    December 3, 2015
    Report Date
    December 3, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). EXAMINATION OF THE RETURNED DEVICE CONFIRMED THAT IMPACTION SHOE IS CRACKED. AN INVESTIGATION WAS CONDUCTED BY THE SUPPLIER ON 28-NOV-2011. IT DETERMINED THAT THE FAILURE OCCURRED AS A RESULT OF CHEMICAL EMBRITTLEMENT OF THE RADEL IMPACTION SHOE DUE TO A COMBINATION OF EXPOSURE TO DISINFECTION CHEMICALS AND SUBSEQUENT HEAT TREATMENT DURING DECONTAMINATION IN THE FIELD. THE CHANGE IN DESIGN WAS APPROVED, ROUTED ON (B)(4), AND IMPLEMENTED ON 02-JANUARY-2014 TO REPLACE THE MATERIAL FOR THE IMPACTION SHOE FROM RADEL 5500 TO PROPYLUX HS IN ADDITION TO REMOVING A THERMAL ATTACHMENT PROCESS (SEE (B)(4)). FURTHER INFORMATION CAN BE FOUND UNDER (B)(4). THE REPORTED DEVICE WAS MANUFACTURED PRIOR TO THE DESIGN CHANGE. ADDITIONAL CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE LOCKING FEMORAL IMPACTOR CRACKED WHILE IMPACTING THE IMPLANT INTO PLACE. **UPDATE (B)(6) 2015** UPON RECEIPT AND EXAMINATION THE IMPACTOR WAS BROKE INTO TWO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820508 HP FEM IMP/EXT KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. 080043

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR