BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EA DELTA CER INSERT 36IDX52OD

    MDR report key: 16706697 · Received April 10, 2023

    Report

    Report Number
    1818910-2023-07538
    Event Type
    Injury
    Date Received
    April 10, 2023
    Date of Event
    March 22, 2023
    Report Date
    April 10, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE CONFIRM THE REPORTED ALLEGATION. THE CERAMIC INSERT WAS FOUND FRACTURED INTO ONE LARGE AND THREE SMALL FRAGMENTS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: THE CERAMIC INSERT BELONGS TO THE SHOP ORDER (B)(4). PROTOCOLS AND ACCEPTANCE CERTIFICATE WERE REVIEWED. THE QUALITY DOCUMENTS SHOW THAT THE DATA OBTAINED ON THE INSERT CONFORMED TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF ANY PRE-EXISTING MATERIAL DEFECT. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [121881752 / 3880268] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. 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. H10 ADDITIONAL NARRATIVE:  ADDED: B5, D9 IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. CORRECTED: H3

    Description of Event or Problem · 0

    LINER BREAKAGE INTRA-OP. DURING THE SUYRERY TOTAL HIP ARTHROPLASTY, CERAMIC LINER WAS BROKEN AT THE RIM. ALL LINER PIECES AND THE FIRST CUP WERE REMOVED OUT, AND THEN REPLACED BY THE LARGER CERAMIC LINER AND CUP TO COMPLETE THE SURGERY.  THE PATIENT WAS IN STABLE CONDITION NOW.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS A SURGICAL DELAY OF 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1753884 EA DELTA CER INSERT 36IDX52OD PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS MRA DEPUY ORTHOPAEDICS INC US 3880268

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Unknown Required Intervention EA DELTA CER INSERT 36IDX52OD| PINNACLE SECTOR II CUP 52MM