BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANCE BONE CEMENT 40G

    MDR report key: 14101850 · Received April 13, 2022

    Report

    Report Number
    1818910-2022-06642
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 28, 2022
    Report Date
    April 13, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    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). INVESTIGATION SUMMARY ==> THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE ALONG WITH PHOTOGRAPHIC EVIDENCE, CONFIRMED THE ALLEGATION. THE PLASTIC CAP OF THE AMPOULE WAS DAMAGED. THE RETAINED SAMPLES WERE TESTED IN A TEMPERATURE AND HUMIDITY-CONTROLLED LABORATORY. THE CEMENT MIXED AND BEHAVED AS EXPECTED FOR THE PRODUCT TYPE AND MET APPROPRIATE SPECIFICATIONS. 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 REVIEWED: 1 NON-CONFORMANCE ON THIS LOT NUMBER; NO IMPACT ON CEMENT PERFORMANCE. FINAL MICRO AND STERILITY TESTS PASSED. PRODUCT MET ALL QUALITY CONTROL ACCEPTANCE CRITERIA. (B)(4) UNITS RELEASED. LOT EXPIRY DATE: 30 JUN 2023 DEVICE HISTORY REVIEW ==> A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (3070040/9552289) PRODUCT AND LOT NUMBERS, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A TKA SURGERY OF BOTH KNEES. DURING THE SURGERY, WHEN THE PACKAGE OF THE PRODUCT WAS OPENED, IT WAS FOUND THAT THE PLASTIC COVER OF THE BOTTLE FOR MONOMER HAD BEEN BROKEN. AFTER THAT, WHEN THE PACKAGE OF ANOTHER SAME PRODUCT WAS OPENED FOR TREATING OPPOSITE SITE, THE PLASTIC COVER OF THAT BOTTLE HAD ALSO BEEN BROKEN. IN EACH CASE, OTHER PRODUCTS WERE USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE SAME EVENT HAD BEEN OCCURRED THE OTHER DAY, AND IT HAS BEEN REPORTED IN (B)(4). NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2670338 ENDURANCE BONE CEMENT 40G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 9552289

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ENDURANCE BONE CEMENT 40G