BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 11/13 32MM +6

    MDR report key: 20693867 · Received November 15, 2024

    Report

    Report Number
    1818910-2024-23861
    Event Type
    Injury
    Date Received
    November 15, 2024
    Date of Event
    November 1, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LZO
    UDI-DI
    10603295033424
    PMA / PMN Number
    K031803
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [136532230/ 4111232] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. 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 ABY PRE-EXISTING MATERIAL DEFECT. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.¿ DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [136532230/ 4111232] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. 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 ABY PRE-EXISTING MATERIAL DEFECT. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [136532230/ 4111232] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. 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 ABY PRE-EXISTING MATERIAL DEFECT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION, WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED, THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THE SURGEON REVISED A 18X13 30+4 S-ROM STEM AND A 50MM PINNACLE CUP. THE PINNACLE CUP WAS DETERMINED, TO BE IMPLANTED TOO FLAT AND ANTEVERTED, DURING A PREVIOUS OPERATION, WHICH HAD LED TO THE 32MM +6 CERAMIC BREAKING. THE S-ROM STEM WAS EXPLANTED AND A 18X13 36+12 STEM WAS IMPLANTED. THE CUP WAS EXPLANTED AND A 58MM REVISION CUP WITH A 36MM CERAMIC HEAD WAS IMPLANTED. THERE WAS NO SURGICAL DELAY. THE NEW STEM PROVIDED GOOD STABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2187745 DELTA CER HEAD 11/13 32MM +6 S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS LZO DEPUY IRELAND - 9616671 4111232 10603295033424

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Required Intervention