BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE PS FEM LT SZ 8 CEM

    MDR report key: 11558847 · Received March 23, 2021

    Report

    Report Number
    1818910-2021-05911
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Date of Event
    March 16, 2021
    Report Date
    March 16, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    OIY
    UDI-DI
    10603295041658
    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. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: DHR REVIEW: PRODUCT CODE 150410108 WORK ORDER (B)(4) WAS MANUFACTURED ON 05-AUG-2020. (B)(4) PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE ARE NO SCRAP PARTS ASSOCIATED WITH LOT 9559098. 2 NCS (NON-CONFORMANCES) FOUND ASSOCIATED WITH LOT 9559098. NR-0153456 ASSOCIATED WITH LOT 9559098 WAS OPENED IN RELATION TO THE GAUGE THAT FAILED SCHEDULED CALIBRATION THEREFORE THERE IS NO CORRELATION BETWEEN NR-0153456 AND THE COMPLAINT FAILURE MODE ¿WHITE FOREIGN MATTER ADHERED TO THE PRODUCT¿. NR-0150695 ASSOCIATED WITH LOT 9559098 WAS OPENED IN RELATION TO THE GAUGE THAT FAILED SCHEDULED CALIBRATION THEREFORE THERE IS NO CORRELATION BETWEEN NR-0150695 AND THE COMPLAINT FAILURE MODE ¿WHITE FOREIGN MATTER ADHERED TO THE PRODUCT¿.

    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

    IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY VIA TKA SURGERY FOR OA WITH THE PRODUCT (150410108) IN QUESTION. DURING THE SURGERY, THE SURGEON OPENED THE PACKAGE OF THE PRODUCT, THE WHITE FOREIGN MATTER, WHICH WAS THE 6 ~ 8 MM SQUARE OBJECT THAT MELTS AND HARDENS WITH HEAT, ADHERED TO THE PRODUCT. THE SURGEON WIPED THE FOREIGN MATTER AND THE SURGERY WAS COMPLETED SUCCESSFULLY USING IT WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452817 ATTUNE PS FEM LT SZ 8 CEM ATTUNE IMPLANT : KNEE FEMORAL OIY DEPUY IRELAND - 9616671 1504-10-108 9559098 10603295041658

    Patients

    Seq Age Sex Outcome Treatment
    1