BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLB SHD END PEG GLEN 48 GBB

    MDR report key: 10507143 · Received September 9, 2020

    Report

    Report Number
    1818910-2020-19612
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    August 19, 2020
    Report Date
    August 18, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. CORRECTIVE ACTION WAS NOT INDICATED. H6 PATIENT CODE: NO CODE AVAILABLE (3191) USED TO CAPTURE THE INSUFFICIENT INFORMATION.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). OCCUPATION: LAWYER. (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 · 1

    IN (B)(6), 2014, THE PATIENT UNDERWENT A TSA (TOTAL SHOULDER ARTHROPLASTY) IN THE SHOULDER JOINT GLENOID TREATING SHOULDER OSTEOARTHROSIS WITHOUT SURGICAL DELAY. ON AN UNKNOWN DATE IT WAS FOUND THAT THE COMPONENT APPEARED TO BE LOOSE. ON (B)(6) 2020 A REVISION PROCEDURE WAS PERFORMED. THE DEVICE WAS THE FIRST USE WHEN THE ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974708 GLB SHD END PEG GLEN 48 GBB GLENOID (KEELED AND 5-PEGGED) IMPLANT : SHOULDER GLENOID KWS DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention GLOBAL ADVANTAGE ECC HD 48X21| GLOBAL ADVANTAGE STEM 12 MM| GLOBAL ADVANTAGE ECC HD 48X21| GLOBAL ADVANTAGE STEM 12 MM