BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EADE RT PM MINI RVS GLENOID

    MDR report key: 14999845 · Received July 13, 2022

    Report

    Report Number
    0001825034-2022-01620
    Event Type
    Injury
    Date Received
    July 13, 2022
    Date of Event
    June 15, 2022
    Report Date
    May 14, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00887868554667
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110030776 CR 40MM GLENOSPHERE STD COCR 65311886; 115399 COMP RVS CNTRL 6.5X45MM ST/RST 853360; 110031402 MINI TRAY STD COCR +3 OFFSET 65163610; 110031427 CR VIVACIT-E 40MM BRNG STD 65164149. REPORT SOURCE: FOREIGN- AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G3, G6, H1, H2, H4, H6, H10 REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: RIGHT REVERSE TSA WITH SEPARATION OF THE GLENOSPHERE AND ASSOCIATED DISLOCATION OF THE GLENOHUMERAL JOINT. BONY FRAGMENTS ARE SEEN IN THE JOINT SPACE, POSSIBLY EVIDENCE OF A FRACTURE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D2, D10, G3, G6, H1, H2, H3, H6, H11. D10: PN: 115399 LN: 853360 COMP RVS CNTRL 6.5X45MM ST/RST. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED TAPER ADAPTOR IDENTIFIED THE DEVICE RETURNED SHOWS SIGNS OF USE AND WEAR AND TEAR. THE POST OF THE TAPER ADAPTOR HAS SOME GALLING AND SOME GOUGES ON THE EXTERIOR DIAMETER. THERE IS ALSO DAMAGE AND BIO-DEBRIS AROUND THE THREADED AREA OF THE POST. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED OF THE BASEPLATE; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICES ARE USED FOR TREATMENT. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO GLENOSPHERE DISSOCIATING FROM THE VRS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S RIGHT SHOULDER WAS REVISED DUE TO GLENOSPHERE DISSOCIATING FROM THE VRS AND THE CENTRAL SCREW LOOSE OR BACKING OUT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734112 EADE RT PM MINI RVS GLENOID PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. 014940 00887868554667

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Hospitalization| R