BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER MINI BASEPLATE WITH TAPER ADAPTER

    MDR report key: 21824740 · Received April 11, 2025

    Report

    Report Number
    0001825034-2025-01072
    Event Type
    Injury
    Date Received
    April 11, 2025
    Date of Event
    March 24, 2025
    Report Date
    May 13, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K193373
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM# 110031424; LOT# 66817505. ITEM# 110031399; LOT# 66714779. ITEM# 115310; LOT# J7689442. G2: FOREIGN: EVENT OCCURRED IN AUSTRALIA. 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 IS FOUND WHICH 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: ITEM# 110031424; LOT# 66817505 ITEM# 110031399; LOT# 66714779 ITEM# 115310; LOT# J7689442 ITEM# UNK 12X55MM STEM; LOT# UNKNOWN ITEM# UNK CENTRAL SCREW; LOT# UNKNOWN ITEM# UNK SCREW; LOT# UNKNOWN ITEM# UNK SCREW; LOT# UNKNOWN ITEM# UNK SCREW; LOT# UNKNOWN ITEM# UNK SCREW; LOT# UNKNOWN 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/CORRECTED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6 VISUAL EXAMINATION OF THE PROVIDED PHOTOS IDENTIFIED THE EXPLANTED GLENOSPHERE WITH THE TAPER ADAPTER ATTACHED. HOWEVER, AS THE PRODUCT WAS NOT RETURNED, FURTHER ANALYSIS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: REVISION OP NOTES- LEFT RTSR DISLOCATED HEMISPHERE ; HEMISPHERE REMOVED ¿ HAD DISLOCATED AND DISPLACED POSTERIORLY ; CAUSE OF DISLOCATION THOUGHT TO BE INFERIOR GLENOID OSTEOPHYTES AND INVERTED HEMISPHERE POLARITY. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. X-RAYS NOT SENT TO MMI AS REVISION RECORDS PROVIDE SUFFICIENT DICTATION OF FINDINGS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. IT WAS INDICATED THAT OSTEOPHYTES MAY HAVE INVERTED THE GLENOSPHERE POLARITY. HOWEVER, WITH THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT WAS CONFIRMED THROUGH THE PROVIDED MEDICAL RECORDS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY SIX (6) WEEKS POST-IMPLANTATION DUE TO DISASSOCIATION OF THE BASEPLATE AND TAPER ADAPTER. IT WAS NOTED THE GLENOSPHERE AND TAPER ADAPTER REMAINED IN-TACT WITH ONE ANOTHER WHEN IT BECAME DISASSOCIATED FROM THE BASEPLATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY SIX (6) WEEKS POST-IMPLANTATION DUE TO DISASSOCIATION OF THE BASEPLATE AND TAPER ADAPTER THAT RESULTED IN A DISLOCATION. DURING THE REVISION, THE SURGEON NOTED THAT THE CAUSE OF THE DISLOCATION WAS THOUGHT TO BE INFERIOR GLENOID OSTEOPHYTES AND INVERTED HEMISPHERE POLARITY. IT WAS NOTED THE GLENOSPHERE AND TAPER ADAPTER REMAINED IN-TACT WITH ONE ANOTHER WHEN IT BECAME DISASSOCIATED FROM THE BASEPLATE. A NEW TRAY, LINER, AND GLENOSPHERE WERE PLACED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2349246 COMPREHENSIVE REVERSE SHOULDER MINI BASEPLATE WITH TAPER ADAPTER SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 66194814

    Patients

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