BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SHOULDER HUMERAL HEAD GLOBAL

    MDR report key: 15063902 · Received July 20, 2022

    Report

    Report Number
    1818910-2022-13454
    Event Type
    Injury
    Date Received
    July 20, 2022
    Date of Event
    February 10, 2022
    Report Date
    July 20, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, 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 MEDWATCH, A FOLLOW-UP MEDWATCH 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. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. DEVICE HISTORY LOT A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. LITERATURE CITATION: GOYA I, SUENAGA N, OIZUMI N, YOSHIOKA C, YAMANE S, YAMAGUCHI H, TOMA T, NISHIDA K. GLENOID WEAR AFTER HUMERAL HEAD REPLACEMENT WITH USING A SINGLE IMPLANT IN PATIENTS WITH CUFF TEAR ARTHROPATHY MORE THAN FIVE YEARS. J ORTHOP SCI. 2022 FEB 10:S0949-2658(22)00018-5. DOI: 10.1016/J.JOS.2022.01.005. EPUB AHEAD OF PRINT. PMID: 35151566. OBJECTIVE/METHODS/STUDY DATA: IN THIS STUDY, 41 SHOULDERS OF 41 PATIENTS (13 MEN, 28 WOMEN) WERE FOLLOWED UP FOR >5 YEARS. THE MEAN PATIENT AGE AT THE TIME OF SURGERY WAS 70.5 YEARS. THE AVERAGE FOLLOW-UP PERIOD AT SHORT-TERM WAS 26.0 MONTHS, AND INTERMEDIATE-TERM WAS 66.5 MONTHS. WE CLASSIFIED GLENOID WEAR INTO FOUR GRADES (I.E., GRADE 0 TO GRADE 3). AGE, SEX, CLINICAL SCORES, AND RANGE OF MOTION WERE INVESTIGATED IN RELATION TO THE GRADE OF GLENOID WEAR. RADIOGRAPHS OF GLENOID WEAR EVALUATED IN THE SHORT-TERM WERE SUBSEQUENTLY COMPARED TO RADIOGRAPHS OBTAINED IN THE INTERMEDIATE-TERM PERIOD. THE ARTICLE REPORTS 5 PATIENTS DIED FOR UNRELATED REASONS. THE REFERENCE TO GLENOID WEAR IS OF THE PATIENT'S NATIVE GLENOID. ALL PATIENTS RECEIVED UNCEMENTED GLOBAL ADVANTAGE HUMERAL HEAD REPLACEMENT WITH CUFF REPAIR/RECONSTRUCTION FOR CUFF TEAR. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 1 DISLOCATION TREATED WITH CLOSED REDUCTION AND BRACE IMMOBILIZATION. RE-DISLOCATION DID NOT OCCUR. GENERAL REPORTS OF TEMPORARY PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404053 UNK SHOULDER HUMERAL HEAD GLOBAL SHOULDER HUMERAL HEAD HSD DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention