BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE SECTOR II CUP 48MM

    MDR report key: 18275715 · Received December 6, 2023

    Report

    Report Number
    1818910-2023-24742
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    November 14, 2023
    Report Date
    December 6, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295009801
    PMA / PMN Number
    P070026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. 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). INVESTIGATION SUMMARY :ACCORDING TO THE INFORMATION RECEIVED, "THE INSERT WAS TOO FAR IN ONE SIDE AND NOT FAR ENOUGH ON THE OTHER. IMPOSSIBLE TO PLACE IT PROPERLY. USE OF ANOTHER DEVICE TO COMPLETE THE PROCEDURE: REMOVAL OF THE CUP PREVIOUSLY PLACED (PRODUCT CODE 121722048 - LOT 4021194) WITH INSERT AND CHANGE OF THE CUP AND THE INSERT. SURGICAL DELAY". THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS REVEALED THAT PINNACLE SECTOR II CUP 48MM WAS RETURNED WITH A CERAMIC LINER FIXATED IN A SLIGHTLY TILTED POSITION. ADDITIONALLY, ORGANIC MATERIAL WAS OBSERVED BETWEEN THE CERAMIC LINER AND THE ACETABULAR CUP. HOWEVER, NO DEFECTS OR SIGNS OF A DEVICE NON CONFORMANCE WERE OBSERVED. A DIMENSIONAL INSPECTION WAS PERFORMED FOR THE PINNACLE SECTOR II CUP 48MM AND MET SPECIFICATION. WITH THE INFORMATION PROVIDED IS NOT POSSIBLE TO DETERMINE A POTENTIAL CAUSE AT THIS MOMENT, HOWEVER IN SUPPORT OF THE EVALUATION PERFORMED, THE OBSERVED CONDITION OF THE INVOLVED IMPLANTS MAY HAVE BEEN CAUSED BY A MISALIGNMENT DURING THE PROCESS OF POSITIONING THE CERAMIC LINER. THE MODE OF FAILURE OF THE DEVICE IS MULTI-FACTORIAL AND CONSIDERATION MUST BE GIVEN TO ALL OTHER POTENTIAL INFLUENCES DURING THE SURGICAL PROCESS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [4021194 / 121722048] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED DURING MANUFACTURING. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE PINNACLE SECTOR II CUP 48MM WOULD 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 : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [4021194 / 121722048] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED DURING MANUFACTURING.

    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

    ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO PATIENT CONSEQUENCE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSERT WAS TOO FAR IN ONE SIDE AND NOT FAR ENOUGH ON THE OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2179821 PINNACLE SECTOR II CUP 48MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS LPH DEPUY ORTHOPAEDICS INC US 4021194 10603295009801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DELTA CER INSERT 32ID X 48OD