BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINN STRAIGHT CUP IMPACTOR

    MDR report key: 4012123 · Received August 15, 2014

    Report

    Report Number
    1818910-2014-25720
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Report Date
    July 30, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED. PREVIOUS INVESTIGATIONS FOUND DESIGN IS ATTRIBUTED TO THE HANDLES CRACKING; ECO 256356 WAS IMPLEMENTED ON (B)(4) 2008 TO CHANGE THE MATERIAL FROM RADEL TO ALUMINUM. THE VENDOR DATE CODE J0804 INDICATES THE INSTRUMENT WAS MANUFACTURED IN AUGUST OF 2004 AND IS OVER 10 YEARS OLD, MADE PRIOR TO THESE CHANGE. IN ADDITION, ECO416321 WAS IMPLEMENTED ON (B)(4) 2013 THAT CHANGED THE MATERIAL FROM ALUMINUM TO OVERMOULDED SILICON. FURTHER CORRECTIVE ACTION IS 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PRIOR TO SURGERY IT WAS DISCOVERED THAT THE HANDLE WAS BROKEN ON THE INSTRUMENT. USED SAME LIKE PRODUCT. NO DELAY. NO AE TO PATIENT. DATE OF EVENT UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490927 PINN STRAIGHT CUP IMPACTOR HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. 1818910 J0804

    Patients

    Seq Age Sex Outcome Treatment
    1