BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL UNITE HEAD 44X18 ECC

    MDR report key: 12833112 · Received November 17, 2021

    Report

    Report Number
    1818910-2021-25457
    Event Type
    Injury
    Date Received
    November 17, 2021
    Date of Event
    November 1, 2021
    Report Date
    November 1, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    PHX
    UDI-DI
    10603295004554
    PMA / PMN Number
    K170748
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. 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. H10 ADDITIONAL NARRATIVE: ADDED: B5 AND D10. 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. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR MANUFACTURING RECORD EVALUATION, WAS NOT POSSIBLE AS THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT : A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). 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

    A. LOT NUMBER: GLOBAL UNITE HEAD 44X18 ECC (110044610/68660Z). B. WAS THE EVENT DUE TO NATURAL PROGRESSION? C. PLEASE CONFIRM THE QUANTITY OF DEPUY CMW 2 20G (3322020/9242374). ANSWER: LOT INFORMATION IS NOT AVAILABLE. IT IS NOT KNOWN IF ITS NATURAL PROGRESSION. IT WOULD HAVE BEEN DEPUY 2 & THE LOT # IS NOT KNOWN.

    Description of Event or Problem · 0

    PATIENT WAS REVISED DUE TO STIFF SHOULDER ON THE LEFT SIDE AND WAS REVISED TO A REVERSE TSA. PATIENT HAS A PRIOR MDR ON (B)(6) 2021. PATIENT HAS A HISTORY OF LEFT TSA WITH LOOSE GLENOID COMPONENT, EXPLANTED AND REVISED ON (B)(6) 2021. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724265 GLOBAL UNITE HEAD 44X18 ECC GLOBAL UNITE IMPLANTS : HUMERAL TRIALS PHX DEPUY IRELAND - 9616671 1100-44-610 10603295004554

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention CROSSLINK ANCHOR PG GLENOID 44| DEPUY CMW 2 20G| DEPUY CMW 2 20G| GLOBAL UNITE HEAD 44X18 ECC