BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 22370778 · Received July 1, 2025

    Report

    Report Number
    0001825034-2025-01919
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    August 8, 2024
    Report Date
    November 13, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304532465
    PMA / PMN Number
    K193373
    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#: 113632, COMP PRIMARY STEM 12MM MINI; LOT#: 66335967 ITEM#: 115310, COMP RVRS SHLDR GLNSP STD 36MM; LOT#: 625110 ITEM#: 180560, COMP NLK SCR 3.5HEX 4.75X30 ST; LOT#: 66008695 ITEM#: 180560, COMP NLK SCR 3.5HEX 4.75X30 ST; LOT#: 66008695 ITEM#: 115396, COMP RVS CNTRL 6.5X30MM ST/RST; LOT#: 66665365 ITEM#: 66450519, MINI STANDARD THICKNESS +0MM TAPER OFFSET 40MM DIAMETER HUMERAL TRAY; LOT#: 66653185 ITEM#: 110031418, STANDARD 36MM DIAMETER BEARING; LOT#: 66259457 H3: 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2; H3; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: GLENOSPHERE TAPER HAS DISASSOCIATED FROM THE BASEPLATE. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. MOST OF THE RECORDS WERE UNRELATED TO THE ZB SHOULDER; HOWEVER, FINDINGS INCLUDE MECHANICAL FAILURE OF THE GLENOSPHERE COMPONENT. NO OTHER ABNORMALITIES ARE NOTED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1; A4; B4; B5; B7; D2; G2; G3; G6; H1; H2; H6. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY ELEVEN (11) MONTHS AGO. SUBSEQUENTLY, THERE HAS BEEN AN ALLEGED UNKNOWN COMPLICATION WITH NO KNOWN INTERVENTION TO DATE. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY ONE (1) YEAR AND THREE (3) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY A MONTH AND A HALF AFTER THEIR INITIAL SURGERY DUE TO A MECHANICAL FAILURE OF THE GLENOSPHERE. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215004 COMP RVRS 25MM BSPLT HA+ADPTR SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 66450519 00880304532465

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Hospitalization| O| R SEE H11 NARRATIVE.