BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SRS MODULAR REGENEREX AUGMENT

    MDR report key: 22610516 · Received July 25, 2025

    Report

    Report Number
    0001825034-2025-02244
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    January 18, 2023
    Report Date
    November 3, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304507876
    PMA / PMN Number
    K173411
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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; E1; E2; E3; G1; G3; G6; H1; H2; H3; H6; H10. THE REPORTED EVENT IS NOT 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. CRFS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PERSISTENT PAIN AND MUSCLE TENDERNESS NEAR CABLE FASTENERS. XRAY/CT SHOWED NO HARDWARE ISSUES ; OT PRESCRIBED. AGAIN ONGOING PAIN, XRAY ¿ NO HARDWARE ISSUES. TRIGGER POINT INJECTION GIVEN. MRI ¿ NEGATIVE. SYMPTOMS GRADUALLY RESOLVED WITHOUT INTERVENTION. STUDY COMPLETION; REMAINS IMPLANTED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): ASSOCIATED PRODUCT INFORMATION: -211218 (125640). -115313 (624810). -211244 (739250). -110027734 (136100). -211228 (480440). ASSOCIATED PRODUCT INFORMATION, PART (LOT) -110031400 (64263046). -110031426 (64291230). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. 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 REPORT 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 THAT A PATIENT ENTERED CLINICAL STUDY UPON REVISION OF RIGHT RTSA WITH REPAIR OF COMMUTED HUMERAL FRACTURE. SUBSEQUENTLY, THE PATIENT EXPERIENCED ONGOING PAIN WITH NO IDENTIFIED IMPLANT ABNORMALITIES AND RECEIVED INJECTION APPROXIMATELY 4 YEARS POST-IMPLANTATION WITH RESOLUTION. REMAINS IMPLANTED AT STUDY COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2173910 COMPREHENSIVE SRS MODULAR REGENEREX AUGMENT SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. 480440 00880304507876

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention SEE H11.