BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE 25MM ADAPTOR

    MDR report key: 21773437 · Received April 4, 2025

    Report

    Report Number
    0001825034-2025-00995
    Event Type
    Injury
    Date Received
    April 4, 2025
    Report Date
    July 28, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    880304532465
    PMA / PMN Number
    K193373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN - AUSTRALIA. D10: MEDICAL PRODUCT: ITEM: EP-115395, LOT: 093300, ITEM NUMBER: E1 44-36 RTNV, +3 HMRL BRG, ITEM: 115310, LOT: 045290, ITEM NUMBER: COMP RVRS, SHLDR GLNSP STD 36MM, ITEM: 115370, LOT: 795950, ITEM NUMBER: COMP RVS TRAY, CO 44MM, ITEM: 113629, LOT: 491120, ITEM NUMBER: COMP PRIMARY, STEM, 9MM MINI, ITEM: 115397, LOT: 478340, ITEM NUMBER: COMP RVS, CNTRL 6.5X35MM ST/RST, ITEM: 180553, LOT: 420680, ITEM NUMBER: COMP LK SCR, 3.5HEX, 4.75X30 ST, ITEM: 180553, LOT: 420680, ITEM NUMBER: COMP LK SCR, 3.5HEX, 4.75X30 ST, ITEM: 180554, LOT: 330090, ITEM NUMBER: COMP LK SCR, 3.5HEX 4.75X35 ST, ITEM: 180554, LOT: 146450, ITEM NUMBER: COMP LK SCR, 3.5HEX 4.75X35 ST. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS PRODUCT IS STILL IMPLANTED ON THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11. H10: RELATED REPORT #S: 0001825034-2025-00722, 0001825034-2025-00724, 0001825034-2025-00723, 0001825034-2025-00726, 0001825034-2025-00727, 0001825034-2025-00725, 0001825034-2025-00728, 0001825034-2025-00730, 0001825034-2025-00729, 0001825034-2025-00731. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR DEVIATIONS AND/OR ANOMALIES. IT CANNOT BE DETERMINED WITH THE PROVIDED INFORMATION IF THE EVENT IS RELATED TO THE RECALL/NCRS ON BASEPLATES. NURSING TIMELINE REVIEWED INFORMATION PROVIDED AND IDENTIFIED THE FOLLOWING: PMI REQUEST RECEIVED, PENDING REVISION DUE TO UNKNOWN REASON. THE REP RESPONSE STATES THAT THE PATIENT WAS BOOKED FOR A REVISION APPROXIMATELY 2 YEARS AGO (UNKNOWN IF THIS IS REFERRING TO KNEE OR SHOULDER PROSTHESIS). MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. BOTH BASEPLATES/TAPER ADAPTERS ARE A PART OF A BET RECALL. THE REASON FOR THIS REVISION IS UNKNOWN, AND THEREFORE, CANNOT BE DETERMINED IF THE REPORTED EVENT IS RELATED TO THE DEVIATIONS/RECALL THE REPORTED EVENT IS NOT CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD AN INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY PERFORMED, WHICH WAS REVISED 4 DAYS LATER DUE TO DISSOCIATION. SUBSEQUENTLY, THE PATIENT IS NOW BEING CONSIDERED FOR A PATIENT MATCHED IMPLANT DUE TO UNKNOWN REASONS.

    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
    633437 COMPREHENSIVE 25MM ADAPTOR SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 230060 880304532465

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Other