BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GLENOSPHERE

    MDR report key: 24489370 · Received March 2, 2026

    Report

    Report Number
    0001822565-2026-00657
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    July 5, 2025
    Report Date
    March 2, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN - THE EVENT OCCURRED IN SOUTH KOREA. G2: LITERATURE - KIM, JI UN; YOON, JI YOUNG; JEON, YOUNG DAE; CHO, HYUNG KI; JEONG, HYEON JANG; OH, JOO HAN JSES INTERNATIONAL, VOLUME 9, ISSUE 6, 2081 - 2086. DOI: 10.1016/J.JSEINT.2025.06.012. D10: ASSOCIATED PRODUCT INFORMATION, PART (LOT): -UNKNOWN BASEPLATE/TAPER(UNKNOWN). E1: ESTABLISHMENT NAME - (B)(6). H6: PROPOSED ANNEX G CODE: MECHANICAL (G04)- HEAD. THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE ZIMMER BIOMET FOR INVESTIGATION, AND THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. 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

    A JOURNAL ARTICLE WAS OBTAINED THAT REPORTED A RETROSPECTIVE STUDY FROM KOREA. THE PURPOSE OF THE STUDY WAS TO DETERMINE WHETHER REVERSE TOTAL SHOULDER ARTHROPLASTY (RTSA) PRODUCES DIFFERENT CLINICAL OUTCOMES DEPENDING ON THE UNDERLYING CONDITION AND SURGICAL HISTORY. THE STUDY REVIEWED 153 PATIENTS WITHIN A TIMEFRAME OF APPROXIMATELY 5 YEARS, ALL PATIENTS RECEIVED COMPREHENSIVE SYSTEM. ALL PROCEDURES WERE PERFORMED UNDER GENERAL ANESTHESIA USING A DELTOPECTORAL APPROACH WITH THE PATIENT IN THE BEACH-CHAIR POSITION. THE SUBSCAPULARIS WAS RELEASED 1 CM MEDIAL TO THE BICIPITAL GROOVE, AND THE HUMERAL NECK WAS CUT ACCORDING TO EACH PATIENT¿S NATIVE RETROVERSION MEASURED ON PREOPERATIVE CT. GLENOID PREPARATION INVOLVED PLACING A GUIDE PIN WITH 10¿15° OF INFERIOR TILT, FOLLOWED BY REAMING TO NEUTRAL VERSION, AND IMPLANTATION OF A 25-MM BASEPLATE WITH A 36-MM GLENOSPHERE FEATURING A 3.5-MM INFERIOR OFFSET. HUMERAL TRAY AND INSERT THICKNESS WERE SELECTED BASED ON STABILITY AND SOFT-TISSUE TENSION DURING TRIALING. WHEN POSSIBLE, THE SUBSCAPULARIS WAS REPAIRED WITH TRANSOSSEOUS SUTURES, AND A BICEPS TENODESIS WAS PERFORMED ALONGSIDE THE REPAIR. THE STUDY COMPARED THE OUTCOMES IN THREE PATIENT GROUPS PRIMARY RTSA FOR MASSIVE ROTATOR CUFF TEAR (MRCT ¿ 24 PATIENTES) WITHOUT OSTEOARTHRITIS, PRIMARY RTSA FOR CUFF TEAR ARTHROPATHY (CTA ¿ 104 PATIENTS), AND SECONDARY RTSA AFTER FAILED ROTATOR CUFF REPAIR (FRCR ¿ 25 PATIENTS). CLINICAL OUTCOME OF REVERSE TOTAL SHOULDER ARTHROPLASTY (COMPREHENSIVE SYSTEM) AFTER FAILED ROTATOR CUFF REPAIR WITH A MEDIUM-TERM FOLLOW-UP: COMPARISON WITH REVERSE TOTAL SHOULDER ARTHROPLASTY FOR MASSIVE ROTATOR CUFF TEAR WITHOUT OSTEOARTHRITIS. THE ARTICLE REPORTED THAT TWO PATIENTS IN THE FRCR GROUP DEVELOPED SCAPULAR NOTCHING ALTHOUGH IT WAS NOT SPECIFIED WHETHER ANY TREATMENT WAS PROVIDED ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122802 UNKNOWN GLENOSPHERE SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11.