BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP PRIMARY STEM 10MM MICRO

    MDR report key: 23610447 · Received November 20, 2025

    Report

    Report Number
    0001825034-2025-03726
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    June 3, 2024
    Report Date
    April 22, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00880304554115
    PMA / PMN Number
    K060692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D2; D4; G1; G3; G6; H1; H2; H3; H6; H10. THE REPORTED CANNOT BE CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. 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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): -115340 (252510), -EP-115394 (344260), -TI115310 (703260), -10000589 (663090), -115395 (819950), -180550 (719610), -180551 (082350), -180550 (855300), -180551 (530640). H6 - PROPOSED ANNEX G: MECHANICAL (G04) - STEM. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED FROM A CLINICAL STUDY THAT A PATIENT HAD AN LEFT TOTAL SHOULDER. SUBSEQUENTLY, THE PATIENT HAS REPORTED AN INCREASE IN SHOULDER PAIN, AT TIMES SEVERE, WITH AN ONSET DATE OF APPROXIMATELY 6 YEARS POSTOP. IT IS UNKNOWN IF REVISION SURGERY IS RECOMMENDED OR PLANNED. NO INTRAOPERATIVE COMPLICATIONS. NO FURTHER INFORMATION REGARDING TREATMENT OR INTERVENTION HAS BEEN PROVIDED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532301 COMP PRIMARY STEM 10MM MICRO PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED MBF ZIMMER BIOMET, INC. 079380 00880304554115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11