BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM REVERSE 36MM GLENOSPHERE

    MDR report key: 23099854 · Received September 19, 2025

    Report

    Report Number
    0001822565-2025-03507
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    August 10, 2022
    Report Date
    November 25, 2025
    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). D10: MEDICAL PRODUCTS: ITEM#: 00434902502, TM RVS BASE PLT 25MM POST +2; LOT#: 64227258. ITEM#: 211216, COMPR SRS PROX BDY - SM 58MM; LOT#: 222230. ITEM#: 211237, COMPR SRS MOD STEM - 10X100MM; LOT#: 321180. ITEM#: 115370, COMP RVS TRAY CO 44MM; LOT#: 795990. ITEM#: EP-115393, E1 44-36 STD HMRL BRNG; LOT#: 247950. ITEM#: 211228, COMPR SRS MOD RGX AUG - SM; LOT#: 978020. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED IN THE PATIENT. H6: COMPONENT CODES: MECHANICAL (G04)- HEAD. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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; G6; H1; H2; H3; H4; H6; H10. THE REPORTED EVENT IS NOT CONFIRMED. REVIEW OF THE REPORTED EVENT BY A HEALTH CARE PROFESSIONAL FOUND THAT TENDONITIS IS THE INFLAMMATION OR IRRITATION OF THE TENDONS, TYPICALLY CAUSED BY REPETITIVE MOTION, OVERUSE, AND PRESSURE TO THE BURSAE. SYMPTOMS CAN INCLUDE PAIN, TENDERNESS, SWELLING, STIFFNESS, DECREASED MOVEMENT, AND/OR REDNESS AT OR AROUND THE JOINT INVOLVED. THIS CONDITION CAN IMPACT THE PATIENT'S ABILITY TO USE THE JOINT FULLY, DECREASE OVERALL ACTIVITIES OF DAILY LIVING (ADLS), RANGE OF MOTION (ROM) OF THE JOINT, AND QUALITY OF LIFE, WHILE INCREASING THE NEED FOR POSSIBLE OVER-THE-COUNTER (OTC) MEDICATIONS FOR SWELLING AND PAIN CONTROL. TREATMENT CAN CONSIST OF OTC MEDICATIONS, PRESCRIBED PAIN MEDICATIONS, PHYSICAL THERAPY, REST, ICE, ELEVATING THE AFFECTED JOINT, AND STEROID INJECTIONS. HETEROTOPIC OSSIFICATION (HO) IS THE ABNORMAL AND RAPID GROWTH OF BONE THAT FORMS WITHIN SOFT TISSUE AS THE RESULT OF HEREDITY, TRAUMA, SURGICAL HISTORY, OR DISEASES OF A JOINT. THE RAPID AND IRREGULAR GROWTH OF BONE OFTEN CAUSES A SHARP OR JUTTED STRUCTURE TO FORM, WHICH CAN RESULT IN PAIN AND IRRITATION TO THE SURROUNDING TISSUES, OR THE PATIENT CAN REMAIN ASYMPTOMATIC. RADIATION OR NONSTEROIDAL ANTI-INFLAMMATORY MEDICATIONS ARE OFTEN PROVIDED TO PREVENT HO FORMATION. THE ONLY TREATMENT, IF NECESSARY, IS SURGICAL EXCISION OR SHAVING/SMOOTHING OUT THE EXCESS BONE. AS TIMEFRAMES OF ONSET DIFFER DUE TO INDIVIDUAL CONTRIBUTING FACTORS, A SPECIFIC TIMEFRAME OF EXPECTED OCCURRENCE CANNOT BE ESTABLISHED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE DEVICE. 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: A1; A2; B4; B5; B7; D2; E1; E2; E3; G1; G2; G3; G6; H1; H2; H6; H10. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY SIX (6) YEARS AND SIX (6) MONTHS AGO. SUBSEQUENTLY, THE PATIENT RECEIVED THREE SEPARATE CORTISONE INJECTIONS DUE TO PAIN AND SIGNS OF TENDONITIS. THE EVENT WAS REPORTED TO BE RESOLVED APPROXIMATELY ONE (1) YEAR AND THREE (3) MONTHS AGO.

    Description of Event or Problem · 0

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

    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
    1397189 TM REVERSE 36MM GLENOSPHERE SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 64107232 00889024269088

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Other| R SEE H11 NARRATIVE.