BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW

    MDR report key: 22285127 · Received June 18, 2025

    Report

    Report Number
    0001825034-2025-01785
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    May 27, 2025
    Report Date
    November 26, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304677074
    PMA / PMN Number
    K193373
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: ITEM#: 110032410; LOT#: 66125641, ITEM#: 180551; LOT#: 66257924, ITEM#: 180551; LOT#: 65918827, ITEM#: 180550; LOT#: 66244332, ITEM#: 180550; LOT#: 66212788, ITEM#: 115310; LOT#: J7431052, ITEM#: 110031405; LOT#: 66100903, ITEM#: 110031424 66064905, ITEM#: 118001 J7888400, ITEM#: 113057 J7405265. IF ANY FURTHER INFORMATION 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) D10: ITEM# 110032410; LOT# 66125641 ITEM# 118001; LOT# J7888400 ITEM# 113057; LOT# J7405265 ITEM# 180551; LOT# 66257924 ITEM# 180551; LOT# 65918827 ITEM# 180550; LOT# 66244332 ITEM# 180550; LOT# 66212788 ITEM# 115310; LOT# J7431052 ITEM# 110031405; LOT# 66100903 ITEM# 110031424; LOT# 66064905 CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6; H10. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: REVERSE TOTAL SHOULDER ARTHROPLASTY WITH LOOSENING OF THE GLENOID COMPONENT. CLOSE APPROXIMATION OF THE INFEROMEDIAL PORTION OF THE HUMERAL COMPONENT AND METAGLENE COULD RESULT IN CONTACT OF THE COMPONENTS DURING ADDUCTION, RESULTING IN THE DESCRIBED FRANK METALLOSIS AT THE TIME OF SURGERY. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL ANATOMICAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE WITH UNKNOWN PRODUCTS. APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS AGO, THE PATIENT WAS REVISED TO A COMPREHENSIVE REVERSE TOTAL SHOULDER ARTHROPLASTY DUE TO GLENOID LOOSENING AND FAILED ROTATOR CUFF. SUBSEQUENTLY, THE PATIENT HAD FALLEN APPROXIMATELY ONE (1) YEAR AND FOUR (4) MONTHS POST-IMPLANTATION AND THEN BEGAN TO HAVE PAIN. RADIOGRAPHIC IMAGING DISPLAYED MALALIGNMENT OF THE GLENOSPHERE, FRACTURED SCREW, LUCENCY AROUND THE INFERIOR LOCKING SCREW, RADIO-DENSE BODIES SUPERIOR IN THE JOINT, AND LIKELY BONY FRAGMENTS INFERIORLY. APPROXIMATELY ONE (1) MONTH AGO, THE PATIENT UNDERWENT A REVISION WHERE A LITTLE BIT OF METALLOSIS OF THE SOFT TISSUE AROUND THE JOINT CAPSULE WAS ENCOUNTERED AND THE CENTRAL SCREW WAS FRACTURED. CANCELLOUS ALLOGRAFT WAS IMPLANTED AND THE PATIENT WAS CONVERTED TO A HEMIARTHROPLASTY WITH PLANS FOR A POSSIBLE REVISION IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY ONE (1) YEAR AND EIGHT (8) MONTHS POST-IMPLANTATION DUE TO A BROKEN CENTRAL SCREW AND A LOOSE GLENOID COMPONENT. SUBSEQUENTLY, THE PATIENT WAS CONVERTED FROM A REVERSE TO A HEMI ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    1684730 COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 66070571 00880304677074

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE NARRATIVE IN H11.