BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERAL HEAD 48.5X17

    MDR report key: 18943091 · Received March 20, 2024

    Report

    Report Number
    1818910-2024-06194
    Event Type
    Injury
    Date Received
    March 20, 2024
    Date of Event
    March 14, 2024
    Report Date
    March 20, 2024
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    MBF
    UDI-DI
    10603295538387
    PMA / PMN Number
    K202716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 # (B0(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT 520048170, LOT 172868 COMBINATION. 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 SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT 520048170, LOT 172868 COMBINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PROGRESSIVE PAIN AND LOSS OF FUNCTION LEFT ARM. DOI: (B)(6) 2022; DOR:(B)(6) 2024; AFFECTED SIDE LEFT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130560 HUMERAL HEAD 48.5X17 SHOULDER IMPLANT - HUMERAL HEAD MBF DEPUY IRELAND - 3015516266 172868 10603295538387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention ANATOMIC GLENOID L 29| ANATOMIC OFFSET TAPER ADAPTER