BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLB SHD END PEG GLEN 48 GBB

    MDR report key: 13335147 · Received January 24, 2022

    Report

    Report Number
    1818910-2022-01499
    Event Type
    Injury
    Date Received
    January 24, 2022
    Date of Event
    January 12, 2022
    Report Date
    January 24, 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). 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Description of Event or Problem · 0

    IN 2011 THE PATIENT UNDERWENT A TSA FOR TREATING OSTEOARTHRITIS IN THE SHOULDER JOINT GLENOID. ON AN UNKNOWN DATE THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO THE LOOSE SHOULDER BLADE COMPONENT. THE SURGEON COMMENTED THE FOLLOWING: 1. AFTER THE SHOULDER BLADE COMPONENT IN QUESTION WAS EXPLANTED, ANY REPLACING DEVICE WAS NOT IMPLANTED IN THE GLENOID. INSTEAD, ILIUM BONE IMPLANTATION WAS APPLIED. THE POLYETHYLENE AREA ON THE EXPLANTED SHOULDER BLADE COMPONENT HAD WORN OUT. 2. A 112852110 HEAD (LOT # D97HY1) WAS REPLACED WITH A 112852120 HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983283 GLB SHD END PEG GLEN 48 GBB GLENOID (KEELED AND 5-PEGGED) IMPLANT : SHOULDER GLENOID HSD DEPUY ORTHOPAEDICS INC US CE3FR1

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention GLOBAL ADVANTAGE ECC HD 52X18 (112852110/D97HY1)