BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE RP PS ARTIC SURF SZ3

    MDR report key: 7514660 · Received May 15, 2018

    Report

    Report Number
    1818910-2018-59657
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Date of Event
    April 19, 2018
    Report Date
    April 19, 2018
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295132837
    PMA / PMN Number
    K140881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT. 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, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATTUNE SIZE 3 RP ARTICULATION SURFACE LOST SPRING DURING DECONTAMINATION PROCESS BY CSP STAFF. THERE WAS NO PATIENT INVOLVEMENT IN EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357437 ATTUNE RP PS ARTIC SURF SZ3 ATTUNE INSTRUMENTS : TIBIAL TRIALS JWH DEPUY IRELAND - 9616671 MVCWP710 10603295132837

    Patients

    Seq Age Sex Outcome Treatment
    1