BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EA DELTA CER INSERT 36IDX52OD

    MDR report key: 7336031 · Received March 13, 2018

    Report

    Report Number
    1818910-2018-55010
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    February 20, 2018
    Report Date
    February 20, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON 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 DEVICE WAS RETURNED AND FAILURE MODE CONFIRMED. THE IMPLANT HAD FRACTURED. ROOT CAUSE UNDETERMINED. 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: NULL. 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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON 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). THE DEVICE WAS RETURNED AND FAILURE MODE CONFIRMED. THE IMPLANT HAD FRACTURED. ROOT CAUSE UNDETERMINED. 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 : NULL. 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 · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 SYNTHESE, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # : (B)(4). INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED AND FAILURE MODE CONFIRMED. THE IMPLANT HAD FRACTURED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHESE 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 : NULL. 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

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT PRODUCT CODE IS SOLD INTERNATIONALLY. IT IS SOLD IN THE US UNDER A DIFFERENT PRODUCT CODE.

    Description of Event or Problem · 1

    EVENT: INSERT CERAMICS BROKE IN IMPACTION. REPORT: ON (B)(6) 2018, IN THE LEFT HIP ARTHROPLASTY SURGERY USING THE INSERT CERAMIC 36X52, IT BROKE AFTER THE FIRST IMPACTION. FOR THIS EVENT, IT WAS VISUALIZED THE TECHNIQUE IN THE SURGICAL TECHNIQUE. IT WAS SEEN THAT THE INSTALLATION THAT IS NOW DONE MANUALLY WITHOUT THE USE OF INSTRUMENTAL AND IT CAUSES THE INSERT TO BREAK. THE INSTRUMENTAL DOES NOT EXIST IN THE BOX, HOWEVER SEEN IN THE MANUAL THAT THIS INSTRUMENTS WOULD SOLVE THE PROBLEM IN THE FAULT. THE SURGEON REQUESTED CLARIFICATION AS TO THE INSTRUMENTS AND TECHNIQUES OF USE SO THAT THE PROBLEM DOES NOT HAPPEN AGAIN. PRODUCT AVAILABLE FOR ANALYSIS. PRODUCT INFORMATION: COD .: 1218-81-752 AND LOT: 8283828.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179704 EA DELTA CER INSERT 36IDX52OD PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS KWA DEPUY ORTHOPAEDICS INC US 8283828

    Patients

    Seq Age Sex Outcome Treatment
    1