BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECLAIM PROX TRIAL SHAFT 75

    MDR report key: 7620320 · Received June 20, 2018

    Report

    Report Number
    1818910-2018-62699
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    May 29, 2018
    Report Date
    May 29, 2018
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LXH
    UDI-DI
    10603295156260
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE COMPLAINT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

    PROBLEM WHILST TRIALING THE HIP WITH THE TRIAL BODY AND NECK, (2975-29-085 AND 2975-31-045) IN THAT THE 2 WERE NOT HOLDING TOGETHER IN ORDER TO SET THE VERSION ON THE TRIAL. REDUCED THE HIP TO ASSESS LENGTH, VERSION ETC, THE NECK TRIAL WAS SLIPPING AROUND THE TRIAL BODY. ON INSPECTION THE TRIAL BODY LOOKED WORN AND ¿FLATTENED¿ AT THE GROOVED SECTION WHERE THE TRIAL NECK SHOULD GRIP IT. TWO OTHER TRIAL BODIES ALSO LOOKED SIMILARLY DAMAGED. 2975-29-075; 2975-29-085; 2975-29-095. THESE ARE THE 3 WHICH APPEAR DAMAGED. THERE WAS ONLY A SLIGHT DELAY OF A FEW MINUTES DURING SURGERY, AND NO HARM CAME TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460169 RECLAIM PROX TRIAL SHAFT 75 RECLAIM INSTRUMENTS : FEMORAL TRIALS LXH DEPUY IRELAND - 9616671 J0811 10603295156260

    Patients

    Seq Age Sex Outcome Treatment
    1