BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE RP TIB BASE SZ 6 POR

    MDR report key: 11362006 · Received February 22, 2021

    Report

    Report Number
    1818910-2021-03601
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    December 22, 2020
    Report Date
    February 16, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295416289
    PMA / PMN Number
    P830055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 (B)(4) WORK ORDER 9409367 WAS MANUFACTURED ON 29-JAN-2020. 16 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE WERE THREE SCRAP PARTS ASSOCIATED WITH LOT 9409367. THE THREE PARTS WERE SCRAPPED OFF AT THE CLEAN AND PASSIVATE STEP IN THE PROCESS. THE THREE PARTS WERE SCRAPPED OUT FOR SCRAP CODE A800: CLAMP MARKS ON THE PERIPHERY. ALL PARTS AT THIS STEP IN THE PROCESS ARE 100 PERCENT INSPECTED USING TM-101171 REV. 6 (ATTUNE TRAYS CLEANLINE INSPECTION) WHERE ALL SURFACES OF THE PART, BOTH POROCOAT AND NON-POROCOAT ARE VISUALLY INSPECTED. THE DEFECT WHICH CAUSED THIS SCRAP IS A VISUAL FAILURE ON THE PERIPHERY OF THE PART WHERE A CLAMP TO HOLD THE PART CAUSED A MARK(S). THIS IS A NON-POROCOAT SURFACE AND THE FAILURE MODE DESCRIBED IS THAT BEAD SHED FROM THE POROCOAT SURFACE. FURTHERMORE, THERE IS A CHAMFER BETWEEN THE PERIPHERY AND THE POROCOAT SURFACE SO THE CLAMP WOULD NOT COME IN CONTACT WITH THE POROCOAT SURFACE. THEREFORE, THE SCRAP HAS NO CORRELATION TO THE FAILURE MODE DESCRIBED. AS THE FAILURE MODE DESCRIBED IS IN RELATION TO THE POROCOAT SURFACE A REVIEW WAS CONDUCTED OF THE POROCOAT LOT WHICH WAS ISSUED TO 9409367. THE LOT IN QUESTION IS 9398854. PRODUCT CODE 150611006P WORK ORDER 9398854 WAS MANUFACTURED ON (B)(6) 2020. THERE WAS ONE SCRAP PART ASSOCIATED WITH LOT 9398854. THE PART WAS SCRAPPED OFF AT THE SINTER STEP IN THE PROCESS. THE PART WAS SCRAPPED OUT FOR SCRAP CODE A025: CASTING DEFECT. THIS SCRAP CODE IS NOT IN RELATION TO THE POROCOAT SURFACE BUT IS A DEFECT FOUND ON THE METAL CASTING WHICH WOULD HAVE BEEN CAUSED PRIOR TO THE POROCOAT BEING APPLIED. THEREFORE, IT HAS NO CORRELATION TO THE FAILURE MODE DESCRIBED. THERE WAS NO NCS (NON-CONFORMANCES) OR DEVIATIONS FOUND TO BE ASSOCIATED WITH EITHER LOT 9409367 OR 9398854.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (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

    IT WAS REPORTED THAT PATIENT HAD A RIGHT TOTAL ATTUNE PRESSFIT KNEE DONE ABOUT 8 WEEKS AGO. THE SURGEON SENT A PICTURE OF THE MEDIAL TIBIAL PEG WITH A BEAD THAT HAS SHED. THE PATIENT WAS NOW DOING WELL. NO SURGICAL DELAY. DOI: (B)(6) 2021, RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255940 ATTUNE RP TIB BASE SZ 6 POR ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY NJL DEPUY IRELAND - 9616671 1506-11-006 9409367 10603295416289

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR