BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE PS FEM LT SZ 4 NAR CEM

    MDR report key: 10843010 · Received November 16, 2020

    Report

    Report Number
    1818910-2020-24653
    Event Type
    Injury
    Date Received
    November 16, 2020
    Date of Event
    October 20, 2020
    Report Date
    October 20, 2020
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    UDI-DI
    10603295041696
    PMA / PMN Number
    K111433
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION SINCE RELEASE FOR DISTRIBUTION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT : PRODUCT CODE 150410124, WORK ORDER (B)(4) WAS MANUFACTURED ON 21/OCTOBER/2014. (B)(4) PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. NO SCRAP ASSOCIATED WITH THIS LOT. NO REPROCESSING ASSOCIATED WITH THIS LOT. ONE DEVIATION FOUND. O NR-0100007 IS ASSOCIATED WITH THIS LOT. THIS WAS RAISED TO ADDRESS THE ISSUE OF THE DRAWING REVISION NUMBER ON THE COMPLETED INSPECTION SHEET FOR ATTUNE PS FEM LT SZ 6 CEM WHICH WAS AT REVISION G AND DID NOT MATCH THE DRAWING REVISION ON THE LOT TRAVELLER WHICH WAS AT REVISION H AT THE ATTUNE INSPECTION WORK STEP. NO RISK TO THE PRODUCT WAS DETERMINED AS NO PRODUCT WAS AFFECTED DUE TO THIS NON-CONFORMANCE. THERE IS NO CORRELATION WITH THE COMPLAINT FAILURE MODE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    FEMORAL IMPLANT DID NOT SEAT WHILE CEMENTING AND HUNG UP MEDIALLY. A LATERAL CONDYLE FRACTURE OCCURRED WHILE IMPACTING. THE ORIGINAL IMPLANT WAS REMOVED. THE FRACTURE WAS ADDRESSED WITH LAG SCREWS. A NEW FEMORAL COMPONENT WAS IMPLANTED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310612 ATTUNE PS FEM LT SZ 4 NAR CEM ATTUNE IMPLANT : KNEE FEMORAL JWH DEPUY IRELAND - 9616671 1504-10-124 8010284 10603295041696

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention UNKNOWN BONE CEMENT| UNKNOWN BONE CEMENT