BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EA DELTA CER INSERT 36IDX52OD

    MDR report key: 17183508 · Received June 22, 2023

    Report

    Report Number
    1818910-2023-12791
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    June 13, 2023
    Report Date
    June 22, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MRA
    PMA / PMN Number
    P070026
    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). 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). INVESTIGATION SUMMARY: LINER BREAKAGE INTRA-OP. DURING THE SURGERY OF TOTAL HIP ARTHROPLASTY, CERAMIC LINER WAS BROKEN AT THE RIM. ALL PIECES WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE RESULTING IN 30MIN DELAY. THE PATIENT WAS IN STABLE CONDITION NOW. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE ALONG WITH SUPPLIER INVESTIGATION PERFORMED BY SUPPLIER. FURTHER DETAILS OF THE DEVICE'S ANALYSIS WERE ATTACHED ON "230925 FINAL REPORT KIV 23 07 09_RP.PDF". VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE RIM OF THE EA DELTA CER INSERT 36IDX52OD HAS FRACTURED IN ONE LAGER AND SEVEN SMALL FRAGMENTS. NEXT TO THE FRACTURE METAL TRANSFER CAN BE FOUND WHICH INDICATES SMALL AREAS OF INTENSIVE CONTACT BETWEEN THE CERAMIC INSERT AND THE METAL CUP. WITH THE INFORMATION PROVIDED IS NOT POSSIBLE TO DETERMINE A POTENTIAL CAUSE AT THIS MOMENT, HOWEVER IN SUPPORT OF THE EVALUATION PERFORMED, THE OBSERVED DAMAGE OF THE EA DELTA CER INSERT 36IDX52OD MAY HAVE BEEN CAUSED BY MISALIGNMENT DURING THE PROCESS OF POSITIONING THE INSERT. ANY CONCLUSIONS FROM THE INVESTIGATIONAL INPUT PROVIDED HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [121881752/ 3935947] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF ANY PRE -EXISTING MATERIAL DEFECT. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE EA DELTA CER INSERT 36IDX52OD 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: THE CERAMIC INSERT BELONGS TO THE SHOP ORDER (B)(4) . PROTOCOLS AND CERTIFICATE OF CONFORMANCE WERE REVIEWED. THE QUALITY DOCUMENTS SHOW THAT THE DATA OBTAINED ON THE INSERT CONFIRMED TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFIL 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/ 3935947] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE SURGERY OF TOTAL HIP ARTHROPLASTY, THE CERAMIC LINER WAS BROKEN AT THE RIM. ALL PIECES WERE REMOVED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE 30 MINUTES DELAY FOR THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589691 EA DELTA CER INSERT 36IDX52OD PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS MRA DEPUY ORTHOPAEDICS INC US 3935947
    79861 EA DELTA CER INSERT 36IDX52OD PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS MRA DEPUY ORTHOPAEDICS INC US 3935947

    Patients

    Seq Age Sex Outcome Treatment
    1 Male