BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICUL/EZE BALL 32 +9 BL

    MDR report key: 18697078 · Received February 13, 2024

    Report

    Report Number
    1818910-2024-03112
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    February 6, 2024
    Report Date
    February 13, 2024
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    JDI
    UDI-DI
    10603295033196
    PMA / PMN Number
    K883460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : PACKAGING MATERIAL A PACKAGE THAT WAS DIFFICULT TO OPEN AND BROKE IN THE OPENING PROCESS. NO DELAYS AFFECTING TIME OR PATIENT. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. NOTE: THE COMPLAINT DEVICE WAS EVALUATE AND INVESTIGATED BY DEPUY SYNTHES. PLEASE REFER TO THE ATTACHMENT (B)(4) INVESTIGATION SUMMARY_SIGNED.PDF. A MANUFACTURING INVESTIGATION WAS PERFORMED, AND IT WAS IDENTIFIED THAT THERE'S NO DEFORMATION ON THE EDGE OF BLISTER BOX, THE GLUE TRANSFER BETWEEN THE OUTER BLISTER BOX AND TYVEK HAS BEEN COMPLETED, AND THERE ARE NO BLISTER CURLING, WINDING EDGE, CAVITY OR OTHER DEFECTS. THIS FAILURE MODE WASN¿T RELATED TO THE PRODUCTION PROCESS. THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL TEST WAS NOT PERFORMED AS IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS UNCONFIRMED AS THE OBSERVED CONDITION OF THE ARTICUL/EZE BALL 32 +9 BL WOULD NOT CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT : PRODUCT CODE 136523000, LOT NUMBER D23022112 WAS MANUFACTURED ON 20-FEB-2023. 56 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIAL MET SPECIFICATION. NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. THE EXPIRY DATE IS 31-JAN-2028. IFU REFERENCE NO. IS IFU-0902-00-701.

    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: 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). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    PACKAGING MATERIAL A PACKAGE THAT WAS DIFFICULT TO OPEN AND BROKE IN THE OPENING PROCESS. THE PAPER ON THE IMPLANT BOX, ON TOP, WAS TORN AND THE IMPLANT COULD NOT BE KEPT STERILE DURING OPENING. THEY TRIED SEVERAL TIMES, BUT IT JUST TORE INTO MORE PIECES. NO DELAYS AFFECTING TIME OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805355 ARTICUL/EZE BALL 32 +9 BL ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY INTERNATIONAL LTD - 8010379 D23022112 10603295033196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown