BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER DOMELOCK, DOME, CENTRIC

    MDR report key: 17754524 · Received September 15, 2023

    Report

    Report Number
    0009613350-2023-00519
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    November 25, 2022
    Report Date
    October 12, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    PHX
    UDI-DI
    00889024485006
    PMA / PMN Number
    K193099
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. DEVICES ARE USED FOR TREATMENT. REPORT FROM CLINICAL STUDY WAS RECEIVED AND REVIEWED FROM A HEALTH CARE PROFESSIONAL. THE PATIENT UNDERWENT A RIGHT ANATOMICAL SHOULDER ARTHROPLASTY DUE TO OMARTHROSIS. SUBSEQUENTLY, THE PATIENT UNDERWENT AN OPEN ROTATOR CUFF REPAIR DUE TO A RUPTURE OF THE CRANIAL FIBERS OF THE SUBSCAPULARIS AND EXTENSIVE INTERSTITIAL CLEAVAGE TEAR OF THE SUPRASPINATUS; NO DEVICE WAS REVISED DURING THE PROCEDURE. LATER, THE PATIENT UNDERWENT A REVISION TO A REVERSE TOTAL SHOULDER FOR INSTABILITY AND TWO EVENTS OF LUXATION: ALL COMPONENTS, EXCEPT FOR STEM, WERE REVISED. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 ¿ MEDICAL DEVICES: ITEM#: 01.04201.123, LOT#: 2979183, ITEM NAME: ANATOMICAL SHOULDER, HUMERAL STEM, UNCEMENTED, 12, 100 MM I; ITEM#: 113952, LOT#: 692830, ITEM NAME: SM HYBRID GLENOID BASE 4MM ; ITEM#: 01.04212.465, LOT#: 2902802, ITEM NAME: ANATOMICAL SHOULDER DOMELOCK, HUMERAL HEAD, 46-16, R=26.1MM. G2 ¿ FOREIGN: BELGIUM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350 - 2023 - 00520. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT AN OPEN ROTATOR CUFF REPAIR DUE TO A RUPTURE OF THE CRANIAL FIBERS OF THE SUBSCAPULARIS AND EXTENSIVE INTERSTITIAL CLEAVAGE TEAR OF THE SUPRASPINATUS; NO DEVICE WAS REVISED DURING THE PROCEDURE. APPROXIMATELY 2 YEARS LATER A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY AND LUXATION OF THE SHOULDER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY AND APPROXIMATELY 2 YEARS LATER A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY OF THE SHOULDER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268568 ANATOMICAL SHOULDER DOMELOCK, DOME, CENTRIC SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2975075 00889024485006

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention| H SEE H10 NARRATIVE.