BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SHOULDER GLENOID GLOBAL

    MDR report key: 15092833 · Received July 25, 2022

    Report

    Report Number
    1818910-2022-13785
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    January 1, 2022
    Report Date
    July 25, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: BORBAS P, TAYLOR DM, LEE S, WIJERATNA M, HOY G, EVANS MC. MEDIUM-TERM CLINICAL AND RADIOGRAPHIC RESULTS OF AN ALL-POLYETHYLENE, PEGGED, BONE-INGROWTH GLENOID COMPONENT: A CONCISE FOLLOW-UP OF A PREVIOUS REPORT. J BONE JOINT SURG AM. 2021 FEB 3;103(3):251-256. DOI: 10.2106/JBJS.20.00084. PMID: 33534293. OBJECTIVE/METHODS/STUDY DATA: TO REPORT ON A 4- 8 YEAR OUTCOMES OF A PREVIOUSLY REPORTED STUDY THAT REPORTED 4 YEAR OUTCOMES. AUTHORS REVISITED THIS PATIENT COHORT TO DETERMINE THE LONGER-TERM CLINICAL AND RADIOGRAPHIC OUTCOMES OF TOTAL SHOULDER REPLACEMENT WITH AN ALL-POLYETHYLENE, PEGGED, HYBRID-FIXATION (BONE INGROWTH AND CEMENT) GLENOID COMPONENT WITH THE AIM OF DETERMINING IF THE OUTCOMES DETERIORATE OVER TIME. DEVICE OF STUDY IS E DEPUY SYNTHES ANCHOR PEG GLENOID COMPONENT. TWO REVISIONS OCCURRED BETWEEN 4 AND YEAR FOLLOW UPS BUT ONE WAS ATTRIBUTED DUE TO A FALL AND MASSIVE CUFF TEAR RESULTING IN PSEDUOPARALYSIS. THE OTHER REVISION IS CAPTURED BY THIS COMPLAINT. CEMENT IS UTILIZE IN PERIPHERAL 3 PEGS AND FIXATED VIA OSTEOINTEGRATION WITH THE CENTRAL PEG. CEMENT MANUFACTURER IS NOT IDENTIFIED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 1 GLENOID LOOSENING (RADIOLUCENCY AROUND ALL 4 PEGS AND FOUND GROSSLY LOOSE INTRAOPERATIVELY) AND ROTATOR CUFF FAILURE REQUIRING REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556105 UNK SHOULDER GLENOID GLOBAL SHOULDER GLENOID  HSD DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention