BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANCE BONE CEMENT 40G

    MDR report key: 10599683 · Received September 29, 2020

    Report

    Report Number
    1818910-2020-20762
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    September 16, 2020
    Report Date
    September 15, 2020
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    PMA / PMN Number
    K023012
    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 ==> THE COMPLAINT STATES: ¿THE PRIMARY SURGERY WAS PERFORMED ON (B)(6). 2020 VIA THA. DURING THE SURGERY, WHEN THE HOSPITAL STAFF OPENED THE PACKAGE OF THE CEMENT, HE/SHE FOUND THAT THERE WAS SOMETHING WRONG WITH THE CEMENT. THE SURGERY WAS COMPLETED WITH ANOTHER CEMENT. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. AS THE PRODUCT SAMPLE WAS NOT RECEIVED FOR EXAMINATION, THIS INVESTIGATION IS BASED ON THE INFORMATION CONTAINED IN THIS COMPLAINT REPORT AND IS LIMITED. THE COMPLAINT INFORMATION DESCRIBES A BROKEN AMPOULE. WITHOUT A SAMPLE OR PHOTOGRAPHS, IT IS NOT POSSIBLE TO ESTABLISH FURTHER INFORMATION FOR THE INVESTIGATION, SUCH AS WHEN THIS DAMAGE ORIGINATED OR HOW SERIOUS THE DAMAGE IS. RETAINED SAMPLES FROM THIS LOT NUMBER WERE CHECKED FOR SIGNS OF THIS FAILURE MODE, BUT NO FURTHER BROKEN AMPOULES WERE DISCOVERED. FMEA DVA-107020-FDE REV 9 LINES 115, 116, 144 AND 145 REFER TO THIS FAILURE MODE (SEE ATTACHMENT ¿PC-(B)(4) EXTRACT FROM DVA-107020-FDE.PDF¿. IN EACH CASE THE RISK IS CONSIDERED ¿AS LOW AS POSSIBLE¿ AND CANNOT BE FURTHER MITIGATED. IN CONCLUSION, THIS IS A KNOWN FAILURE MODE AND THE CURRENT RATE OF COMPLAINTS FOR THIS ISSUE IS WITHIN THE EXPECTED OCCURRENCE RATE NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATED THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY THE NUMBER OF COMPLAINTS RECEIVED FOR THIS FAILURE MODE WILL CONTINUE TO BE MONITORED AND PRODUCT UPDATES/ RECOMMENDATIONS WILL BE IMPLEMENTED AT THE POST MARKET SURVEILLANCE REVIEW DEPENDENT UPON OCCURRENCE RATINGS. 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 REQUIRED. DEVICE HISTORY LOT ==> DEVICE HISTORY REVIEWED FOR LOT NO 9242399: 3 UNRELATED NON-CONFORMANCES ON THIS LOT NUMBER. FINAL MICRO AND STERILITY TESTS PASSED. QC RELEASE SPECIFICATIONS MET 2740 UNITS RELEASED. LOT EXPIRY DATE: 31-JUL-22.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020, VIA THA. DURING THE SURGERY, WHEN THE HOSPITAL STAFF OPENED THE PACKAGE OF THE CEMENT, SURGEON FOUND THAT THERE WAS SOMETHING WRONG WITH THE CEMENT. IT WAS CONFIRMED THAT WHEN THE STAFF OPENED THE OUTER BOX AND REMOVED THE LIQUID BOTTLE, THE INSIDE OF THE STERILIZATION PACK COULD NOT BE CHECKED BECAUSE THE INSIDE OF THE PACK WAS DISCOLORED TO GREEN. THE LIQUID BOTTLE MIGHT BE CRACKED IN THE STERILE PACK. THE SURGERY WAS COMPLETED WITH ANOTHER CEMENT. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063060 ENDURANCE BONE CEMENT 40G BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 9242399

    Patients

    Seq Age Sex Outcome Treatment
    1