BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLB SHD END PEG GLEN 44 GBB

    MDR report key: 23707054 · Received December 3, 2025

    Report

    Report Number
    1818910-2025-21092
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    November 13, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWS
    UDI-DI
    10603295007258
    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). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION THAT 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 RECON DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: D9, H4. CORRECTED: D4 CATALOG. IF INFORMATION THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT IS OBTAINED, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    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. ADDITIONAL NARRATIVE: D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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

    IT WAS REPORTED THE INITIAL SURGERY WAS TSA (TOTAL SHOULDER ARTHROPLASTY) COMPLETED ON (B)(6) 2017. THE REVISION SURGERY PERFORMED ON (B)(6) 2025 WAS DUE TO PAIN CAUSED BY A TRAUMATIC SUBSCAPULARIS TENDON RUPTURE. IT WAS THOUGHT THAT WEAR OF THE GLENOID COMPONENT MAY ALSO BE INVOLVED. IN THE REVISION SURGERY, THE HEAD WAS REMOVED, AND THE GLENOID COMPONENT WAS EXTRACTED. IT WAS CONFIRMED THAT THE GLENOID COMPONENT WAS WORN. THE SURGEON THEN USED A THIN-BLADED CHISEL TO REMOVE THE UNITE BODY, LEAVING THE STEM IN PLACE. THE SURGEON THEN REAMED THE SCAPULA, FIXED THE METAGRENE WITH SCREWS, AND PLACED THE GLENOSPHERE. THE SURGEON ADJUSTED THE HUMERUS RETROVERSION ANGLE TO 20°, PLACED THE EPIPHYSIS, AND THEN INSERTED A 383 CUP TO COMPLETE THE OPERATION. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2787397 GLB SHD END PEG GLEN 44 GBB GLENOID (KEELED AND 5-PEGGED) IMPLANT : SHOULDER GLENOID KWS DEPUY ORTHOPAEDICS INC US 472820 10603295007258

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention