BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE RP TIB BASE SZ 6 CEM

    MDR report key: 12174114 · Received July 15, 2021

    Report

    Report Number
    1818910-2021-15299
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 25, 2021
    Report Date
    June 25, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    UDI-DI
    10603295492184
    PMA / PMN Number
    P830055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: FINISH GOOD WORK ORDER (B)(4). PRODUCT CODE 150680006, WORK ORDER (B)(4) WAS MANUFACTURED ON 19-NOV-2020. 20 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE WAS NO SCRAP ASSOCIATED WITH THIS LOT. THERE WAS NO MATERIAL REPROCESSING REPORTS (MRR) ASSOCIATED WITH THIS LOT. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. FOUNDRY CASTING WORK ORDER (B)(4). PRODUCT CODE 150610306, WORK ORDER (B)(4) WAS MANUFACTURED ON 28-OCT-2020. 19 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE WERE FIVE (5) SCRAP PARTS ASSOCIATED WITH LOT 9583597. TWO (2) PARTS WERE SCRAPED AT THE BOILERCLAVE PROCESS STEP FOR REASON CODE A377: PARTS MISSING - BEFORE BOILERCLAVE, AS PARTS WERE KNOCKED OFF DURING THE SHELL COATING PROCESS. ALL CASTINGS AT THE BOILERCLAVE PROCESS STEP ARE 100% VISUALLY INSPECTED AS PER TM-101276 (TEST METHOD FOR THE INSPECT OF CERAMIC MOULDS) THREE (3) PARTS WERE SCRAPED AT THE GATE REMOVAL AND INSPECT & DRESS PROCESS STEP FOR REASON CODE A276: CERAMIC DEFECTS (POST CAST). ALL PARTS AT THE GATE REMOVAL AND INSPECT & DRESS PROCESS STEP ARE 100% VISUALLY INSPECTED AS PER TM-101933 (TRAYS INSPECT AND DRESS VISUAL INSPECTION (ATTUNE). ALL SCRAP PARTS WERE REMOVED FROM LOT 9583597 AS PER SCP-CSOP0619 SCRAP PROCEDURE, THEREFORE THERE IS NO CORRELATION WITH THE COMPLAINT FAILURE MODE. THERE WAS NO MATERIAL REPROCESSING REPORTS (MRR) ASSOCIATED WITH THIS LOT. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. FOUNDRY CASTING WORK ORDER (B)(4). PRODUCT CODE 150610306, WORK ORDER (B)(4) WAS MANUFACTURED ON 27-OCT-2020. 18 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. SCRAP: THERE WERE SIX (6) SCRAP PARTS ASSOCIATED WITH LOT 9583599. TWO (2) PARTS WERE SCRAPPED AT THE BOILERCLAVE PROCESS STEP FOR REASON CODE A377: PARTS MISSING - BEFORE BOILERCLAVE, AS PARTS WERE KNOCKED OFF DURING THE SHELL COATING PROCESS. ALL CASTINGS AT THE BOILERCLAVE PROCESS STEP ARE 100% VISUALLY INSPECTED AS PER TM-101276 (TEST METHOD FOR THE INSPECT OF CERAMIC MOULDS) TWO (2) PARTS WERE SCRAPPED AT THE GATE REMOVAL AND INSPECT & DRESS PROCESS STEP FOR REASON CODE A276: CERAMIC DEFECTS (POST CAST). ALL PARTS AT THE GATE REMOVAL AND INSPECT & DRESS PROCESS STEP ARE 100% VISUALLY INSPECTED AS PER TM-101933 (TRAYS INSPECT AND DRESS VISUAL INSPECTION (ATTUNE). TWO (2) PARTS WERE SCRAPPED AT THE AT THE FOUNDRY X-RAY PROCESS STEP FOR REASON CODE A276: CERAMIC DEFECTS (POST CAST). ALL PARTS AT THE FOUNDRY X-RAY PROCESS STEP IN THE PROCESS ARE 100% VISUALLY INSPECTED AS PER TM-100830 (FOUNDRY X-RAY INTERPRETATION). ALL SCRAP PARTS WERE REMOVED FROM LOT 9583599 AS PER SCP-CSOP0619 SCRAP PROCEDURE, THEREFORE THERE IS NO CORRELATION WITH THE COMPLAINT FAILURE MODE. REPROCESSING: THERE WAS NO MATERIAL REPROCESSING REPORTS (MRR) ASSOCIATED WITH THIS LOT. NON-CONFORMANCE: THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT.

    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 ON (B)(6) 2021, THE PATIENT UNDERWENT THE TKA SURGERY FOR OA WITH THE TIBIAL TRAY IN QUESTION. DURING THE SURGERY, IT WAS CONFIRMED THAT THERE WERE TRACES OF DIRT AND PROTECTIVE COVERS ON THE SURFACE OF THE TRAY. THE SURGEON WIPED IT WITH A GAUZE, BUT SOME TRACES REMAINED. THE TRAY WAS USED AS IT WAS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068908 ATTUNE RP TIB BASE SZ 6 CEM KNEE TIBIAL TRAY NJL DEPUY IRELAND - 9616671 1506-80-006 9637581 10603295492184

    Patients

    Seq Age Sex Outcome Treatment
    1