BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM REVERSE 36MM GLENOSPHERE

    MDR report key: 23653233 · Received November 25, 2025

    Report

    Report Number
    0001822565-2025-04315
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    September 22, 2022
    Report Date
    April 8, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00889024269088
    PMA / PMN Number
    K130661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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): 00434903611(63325053), ASSOCIATED PRODUCT INFORMATION: 211216(527760), 211239(357120), 115370(347800), EP-115394(213470), 211228(262520), 211228(262540). 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 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D2; G1; G3; G4; G6; H1; H2; H3; H6; H10. THE REPORTED EVENT IS CONFIRMED THROUGH EVALUATION OF MEDICAL RECORDS. 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. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT EXPERIENCED POST-OP ACHING, PINCHING PAIN AND MINIMAL STIFFNESS AFTER R-SHOULDER SURGERY, MANAGED WITH PT AND INJECTIONS. PERSISTENT PAIN NOTED AGAIN IN A POSTERIOR VISIT. MILD IN SEVERITY, TREATMENT: PT PRESCRIBED; INJECTIONS TO DELTOID ADMINISTERED. STUDY COMPLETE WITH ALL COMPONENTS INTACT. 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 DURING A CLINICAL STUDY A PATIENT HAD AN INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY. APPROXIMATELY 15 DAYS POST-IMPLANTATION, THE PATIENT COMPLAINED OF PAIN AND RECEIVED A STEROID INJECTION INTO THE DELTOID MUSCLE. POSTERIORLY, APPROXIMATELY 5 YEARS LATER, PERSISTENT PAIN WAS REPORTED WITH NO TREATMENT. FINALLY, APPROXIMATELY 5 YEARS POST-IMPLANTATION, THE STUDY WAS COMPLETE WITH ALL COMPONENTS REMAINING IMPLANTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433102 TM REVERSE 36MM GLENOSPHERE SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. 63325053 00889024269088

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other SEE H11.