BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*HEAD FEMORAL COCR 32+6

    MDR report key: 19569779 · Received June 19, 2024

    Report

    Report Number
    1818910-2024-13343
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    June 7, 2024
    Report Date
    June 19, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    UDI-DI
    10603295170839
    PMA / PMN Number
    K920317
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 (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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. PRODUCT DESCRIPTION:- S-ROM*HEAD FEMORAL COCR 32+6. PRODUCT CODE:(B)(4). LOT NO:- 1043585. QUANTITY OF MANUFACTURED:(B)(4). DATE OF MANUFACTURING:- 16-AUG-2002. EXPIRY DATE:- 31-AUG-2008 . 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 : PRODUCT DESCRIPTION:- S-ROM*HEAD FEMORAL COCR 32+6. PRODUCT CODE:(B)(4). LOT NO:- 1043585. QUANTITY OF MANUFACTURED:(B)(4). DATE OF MANUFACTURING:- 16-AUG-2002. EXPIRY DATE:- 31-AUG-2008. DEVICE HISTORY REVIEW : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Description of Event or Problem · 0

    PATIENT WAS REVISED DUE TO DISLOCATION OF HIP. SURGEON IMPLANTED A COMPETITOR CUP. SURGEON REMOVED LINER AND PLACED A COMPETITOR CONSTRAINED LINER WITH A SROM HEAD. DOI: (B)(6) 2003. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624659 S-ROM*HEAD FEMORAL COCR 32+6 S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS INC US 1043585 10603295170839

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention COMPETITOR LINER.| ZIMMER CUP.