BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER¿¢ DOMELOCK®, DOME, CENTRIC

    MDR report key: 17168619 · Received June 21, 2023

    Report

    Report Number
    0009613350-2023-00302
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    January 15, 2018
    Report Date
    August 31, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    PHX
    UDI-DI
    00889024485006
    PMA / PMN Number
    K193099
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00301 ; 0009613350-2023-00303 ; 0009613350-2023-00304 . G2: FOREIGN- SWITZERLAND. D10: ASSOCIATED PRODUCTS: ITEM NUMBER: 01.04201.103, ITEM NAME: ANATOMICAL SHOULDER¿, HUMERAL STEM, UNCEMENTED, Ø 10.5, 100 MM, ITEM LOT: 2835291 . ITEM NUMBER: 01.04214.370, ITEM NAME: ANATOMICAL SHOULDER¿¢, GLENOID, PEGGED, CEMENTED, M, ITEM LOT: 2841275. ITEM NUMBER: 01.04212.445, ITEM NAME: ANATOMICAL SHOULDER¿ DOMELOCK®, HUMERAL HEAD, Ø44-16, R=24.4MM, M, ITEM LOT: 2813408. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D2, D9, G1, G3, G6, H1, H2, H3, H6, H10. THE DEVICES REMAIN IMPLANTED; 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. MEDICAL RECORDS AND RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED AN INITIAL LEFT TOTAL SHOULDER REPLACEMENT ON (B)(6), 2016. SUBSEQUENTLY, ON (B)(6), 2018, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY DUE TO FROZEN SHOULDER, IMPINGEMENT SYNDROME, AND UNKNOWN CEMENT THAT LEAKED INTO THE SPINOGLENOID NOTCH. NO ADDITIONAL COMPLICATIONS HAVE BEEN REPORTED AT THE 7 YEAR FOLLOW-UP AND THE PATIENT REPORTED TO BE VERY SATISFIED. TWO X-RAY VIEWS OF THE LEFT SHOULDER DEMONSTRATE A LEFT SHOULDER ARTHROPLASTY WITH RADIOLUCENT GLENOID COMPONENT. NO EVIDENCE FOR HARDWARE FAILURE OR LOOSENING AND NO FRACTURE IS SEEN. POSSIBLE ROTATOR CUFF REPAIR. BASED ON THE RECEIVED MEDICAL RECORDS, A POTENTIAL CAUSE APPEARS TO BE THE CEMENT LEAKAGE INTO THE SPINOGLENOID NOTCH. NEVERTHELESS, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WITH LEFT TOTAL SHOULDER REPLACEMENT UNDERWENT AN ADDITIONAL SURGERY DUE TO FROZEN SHOULDER, IMPINGEMENT SYNDROME, AND UNKNOWN CEMENT LEAKED INTO THE SPINOGLENOID NOTCH. NO ADDITIONAL COMPLICATIONS HAVE BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987127 ANATOMICAL SHOULDER¿¢ DOMELOCK®, DOME, CENTRIC SHOULDER PROSTHESIS PHX ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2853488 00889024485006

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10