BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR PLATE SIZE 48

    MDR report key: 18118259 · Received November 13, 2023

    Report

    Report Number
    1818910-2023-23016
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Date of Event
    December 18, 2020
    Report Date
    November 13, 2023
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    PKC
    UDI-DI
    10603295381129
    PMA / PMN Number
    K212683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: ANCHOR PLATE SIZE 48, PRODUCT CODE: 114010048, LOT NUMBER: 8614698. 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 23-10-2017, 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO, 4) EXPIRY DATE: 30-09-2027, 5) IFU REFERENCE: 090200874. 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: ANCHOR PLATE SIZE 48, PRODUCT CODE: 114010048, LOT NUMBER: 8614698. 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 23-10-2017, 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO, 4) EXPIRY DATE: 30-09-2027, 5) IFU REFERENCE: 090200874.

    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

    CLINICAL ADVERSE EVENT RECEIVED FOR GLENOID FRACTURE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2020. (RIGHT SHOULDER) TREATMENT: NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108954 ANCHOR PLATE SIZE 48 SHOULDER HUMERAL STEM ACCESSORY PKC DEPUY IRELAND - 9616671 8614698 10603295381129

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female CROSSLINK ANCHOR PG GLENOID 48| HUMERAL HEAD SIZE 50