BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY/CMW 2G

    MDR report key: 17606919 · Received August 23, 2023

    Report

    Report Number
    1818910-2023-17304
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    August 4, 2023
    Report Date
    August 23, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    MBB
    UDI-DI
    10603295174271
    PMA / PMN Number
    K081163
    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). H6 COMPONENT CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (G07002) USED TO CAPTURE NO FINDINGS AVAILABLE. DMF: 13704. TRADE NAME: GENTAMICIN SULPHATE. ACTIVE INGREDIENT(S): GENTAMICIN SULPHATE. DOSAGE FORM: POWDER. STRENGTH: 1.0G ACTIVE IN OUR CEMENTS. INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

    PATIENT WAS CONVERTED TO A REVERSE SHOULDER AS THE SURGEON STATED THAT HE BELIEVED THE PATIENT TORE HER RC DURING THERAPY AND MADE THE JOINT UNSTABLE AND WAS ROCKING THE GLENOID IMPLANT AND IT LOOSENED AND BECAME DISLODGED. LOOSENING OF THE GLENOID COMPONENT AT THE BONE TO CEMENT INTERFACE WAS REPORTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524747 DEPUY/CMW 2G BONE CEMENT : BONE CEMENT MBB DEPUY IRELAND - 9616671 3899366 10603295174271

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention ANATOMIC GLENOID S 24| ANATOMIC OFFSET TAPER ADAPTER| HUMERAL HEAD 48.5X19.5