BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE PS RP INSRT SZ 8 8MM

    MDR report key: 8133964 · Received December 5, 2018

    Report

    Report Number
    1818910-2018-77282
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    August 10, 2018
    Report Date
    November 8, 2018
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    NJL
    UDI-DI
    10603295052876
    PMA / PMN Number
    P830055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FINDS POLYETHYLENE WEAR. 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. DEVICE HISTORY LOT: PRODUCT CODE: 151650808, LOT NUMBER: 7070200. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: PRODUCT CODE: 151650808, WORK ORDER: 7070200, WAS MANUFACTURED ON DATE 19-AUG-2013, 16 PARTS WERE MANUFACTURED. (B)(6). 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 EVALUATION OF THE RETURNED DEVICE FINDS POLYETHYLENE WEAR. 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. DEVICE HISTORY LOT - PRODUCT CODE 151650808, LOT NUMBER 7070200. DEVICE HISTORY REVIEW - PRODUCT CODE 151650808 WORK ORDER (B)(4) WAS MANUFACTURED ON DATE 19-AUG-2013, (B)(4) PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. 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

    REVISION DUE TO INFECTION AND INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974567 ATTUNE PS RP INSRT SZ 8 8MM ATTUNE IMPLANT : KNEE TIBIAL INSERT NJL DEPUY IRELAND 9616671 7070200 10603295052876

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR