BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE RP TIB BASE SZ 6 POR

    MDR report key: 12422215 · Received September 3, 2021

    Report

    Report Number
    1818910-2021-19310
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    March 11, 2021
    Report Date
    January 25, 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. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT ==> DEVICE HISTORY RECORD REVIEW WAS PERFORMED. PRODUCT CODE (B)(4), WORK ORDER(B)(4) WAS MANUFACTURED ON 24-JUNE-2020.(B)(4): PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. SCRAP: 2 PARTS FROM THIS LOT WERE SCRAPPED. THE PARTS WERE SCRAPPED FOR REASON CODE A164 (PART THICKNESS) AT STAGE 1 LAP. ALL PARTS WERE INSPECTED AS PER (B)(6) REV 1 (TM ATTUNE CEMENTLESS RP TIBIAL BASES KEMET THICKNESS INSPECTION POST STAGE 1) WITH THE 2 PARTS FAILING BEING SCRAPPED. FURTHERMORE, AT THE AQUABLAST PROCESS STEP ALL PARTS ARE INSPECTED FOR THE PRESENCE OF RAISED POROCOAT OR DELAMINATION. AS PER 103071597 REV 3 (SWS ATTUNE CEMENTLESS RP TIB BASE AQUABLAST TRAYS VS) JEC 1 ¿PICKING IS ACCEPTABLE TO CONFIRM IF RAISED BEADS OR DELAMINATION PRESENT, FOLLOWED BY AQUABLAST ONLY. PICKING USED TO AID REMOVAL OF RAISED BEADS. TO VERIFY THE POROCOAT BEAD BOND INTEGRITY AFTER PICKING OF BEADS.¿ REPROCESSING: 4 PARTS FROM THIS LOT WERE REPROCESSED: (B)(4): THIS CONCERNS CLOUDS: ON FACE. THERE IS NO CORRELATION BETWEEN THIS REPROCESSING AND THE FAILURE MODE OF THE COMPLAINT. NON-CONFORMANCE: THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE:  ADDED: D4 (EXPIRATION DATE) IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. CORRECTED: H8.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NOT A REVISION. COMPONENTS ARE SOLID AT THIS POINT.

    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

    COMPASS CASE REPORT (B)(4): THIS PATIENT HAD BILATERAL ATTUNE PRESSFIT KNEES. WHEN THE SURGEON LOOKED AT POST-OP IMAGES, IT WAS NOTICED THAT THE LEFT KNEE TIBIAL TRAY HAD SOME POROUS COATING THAT HAD COME OFF. THE SURGEON CAN SEE BEADS THAT HAD BROKEN AWAY FROM THE PERIPHERAL PEGS. THE SURGEON BELIEVES THIS HAPPENS DUE TO THE TIGHT PRESSFIT THAT HAS THE POTENTIAL TO SCRAPE OFF BEADS. NO DELAY IN SURGERY. DOE: (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320605 ATTUNE RP TIB BASE SZ 6 POR ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY NJL DEPUY IRELAND - 9616671 1506-11-006 9541709 10603295416289

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR