BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER DOMELOCK, DOME, CENTRIC

    MDR report key: 17133931 · Received June 15, 2023

    Report

    Report Number
    0009613350-2023-00285
    Event Type
    Injury
    Date Received
    June 15, 2023
    Date of Event
    May 4, 2023
    Report Date
    September 6, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    PHX
    UDI-DI
    00889024275188
    PMA / PMN Number
    K193099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE DEVICES WERE DISCARDED; 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 WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. THE REVIEW IDENTIFIED THAT THE PATIENT HAD AN ANATOMICAL TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, DURING THE 7-YEAR FOLLOW-UP, THE PATIENT REPORTED MODERATE PAIN AND LIMITED RANGE OF MOTION. UNDERWENT A CONVERSION TO A REVERSE TOTAL SHOULDER DUE TO INSUFFICIENT SUBSCAPULAR, SUPRASPINATUS, AND INFRASPINATUS TENDONS. ALL COMPONENTS WERE REVISED EXCEPT FOR THE STEM AND NO ADDITIONAL INFORMATION WAS PROVIDED. BASED ON THE RECEIVED MEDICAL RECORDS, A POTENTIAL CAUSE APPEARS TO BE AN INSUFFICIENCY OF THE SUBSCAPULAR, SUPRASPINATUS, AND INFRASPINATUS TENDONS. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM# 0104212465; LOT#2834589; ITEM NAME# ANATOMICAL SHOULDER DOMELOCK, HUMERAL HEAD, 46-16, R=26.1MM. ITEM# 0104214370; LOT#2850137; ITEM NAME# ANATOMICAL SHOULDER, GLENOID, PEGGED, CEMENTED, M. ITEM# 0104211103; LOT#2684383; ITEM NAME# HUMERAL STEM CMNTD 10.5-100. G2- SWITZERLAND. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00286 AND 0009613350-2023-00288.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT HAD AN ANATOMICAL TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, DURING THE 7 YEAR FOLLOW-UP, REPORTED MODERATE PAIN AND LIMITED RANGE OF MOTION. PATIENT UNDERWENT A CONVERSION TO A REVERSE TOTAL SHOULDER DUE TO INSUFFICIENT SUBSCAPULAR, SUPRASPINATUS AND INFRASPINATUS. ALL COMPONENTS WERE REVISED EXCEPT FOR THE STEM AND NO ADDITIONAL INFORMATION WAS PROVIDED. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229929 ANATOMICAL SHOULDER DOMELOCK, DOME, CENTRIC SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2853488 00889024275188

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Hospitalization| R SEE H10 NARRATIVE