BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN KNEE INSTRUMENT

    MDR report key: 8782099 · Received July 11, 2019

    Report

    Report Number
    1818910-2019-98118
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    June 21, 2019
    Report Date
    June 21, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT STATES: ¿IT WAS REPORTED THAT THE TIP OF THE HOSE OF THE JOINT PART WHICH FOR CONNECTING THE FOOT PUMP OF THE CEMENT (P/N: 3172050) WAS BROKEN DURING THE TKA SURGERY ON (B)(6) 2019 WHEN THE FOOT PUMP AND THE SUCTION HOSE WERE CONNECTED. THE SURGERY WAS COMPLETED WITHIN A 30 MINUTES SURGICAL DELAY BY USING ALTERNATIVE CEMENT (P/N: 3172080). NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.¿ THE COMPLAINT DESCRIPTION IMPLIES THAT THE CARBON FILTER (¿THE TIP OF THE HOSE OF THE JOINT PART¿) WAS BROKEN DURING USE. THE CARBON FILTER IS A COMPONENT PART OF PRODUCT CODE 3172050. NO PHYSICAL SAMPLE OR PHOTOGRAPHS HAVE BEEN SUPPLIED TO SUPPORT THE COMPLAINT DESCRIPTION. THIS COMPLAINT CANNOT BE CONFIRMED. DVA-104409-FDE REV 10 WAS REVIEWED, AND THIS POTENTIAL FAILURE IS INCLUDED ON LINES 360-361. IN EACH CASE, THE RISK IS CONSIDERED ¿AS LOW AS POSSIBLE¿ AND CANNOT BE FURTHER MITIGATED. 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: NO LOT IDENTIFICATION DETAILS AVAILABLE. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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 THE TIP OF THE HOSE OF THE JOINT PART WHICH FOR CONNECTING THE FOOT PUMP OF THE CEMENT (P/N: 3172050) WAS BROKEN DURING THE TKA SURGERY ON (B)(6) 2019 WHEN THE FOOT PUMP AND THE SUCTION HOSE WERE CONNECTED. THE SURGERY WAS COMPLETED WITHIN A 30 MINUTES SURGICAL DELAY BY USING ALTERNATIVE CEMENT (P/N: 3172080). NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574161 UNKNOWN KNEE INSTRUMENT KNEE INSTRUMENT LXH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1