BEUDAMED
    FDA Adverse Event Injury Summary report: N

    15MM POST LENGTH BASE PLATE

    MDR report key: 21864457 · Received April 18, 2025

    Report

    Report Number
    0001822565-2025-01047
    Event Type
    Injury
    Date Received
    April 18, 2025
    Date of Event
    April 4, 2025
    Report Date
    October 31, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00889024268999
    PMA / PMN Number
    K121543
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. 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. THE FOLLOWING SECTIONS WERE UPDATED: B3, B4, D2, D6, G3, G6, H1, H2, H4, H11. THE FOLLOWING SECTIONS WERE CORRECTED: B2, B5, D1, D4, G4, H6. D10: CAT: 01.04223.036, LOT: 2937875 INVERS/REVERS SCR SYST 4.5-36. CAT: 01.04223.036, LOT: 2823876 INVERS/REVERS SCR SYST 4.5-36. 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; H6. B3 - EVENT DATE - UNKNOWN DAY IN MARCH 2025. THE REPORTED EVENT IS CONFIRMED. 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 RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 A LEFT SHOULDER ARTHROPLASTY SEVEN YEARS BACK. THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT DUE TO PAIN AND LOOSENING. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE AND NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REVISED SEVEN YEARS POST-INITIAL IMPLANTATION DUE TO PAIN AND LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT THE PATIENT'S TMR HAS A TENDENCY TO DISLOCATE SINCE A FEW YEARS PRIOR TO THE REVISION PROCEDURE AND THE PAIN STARTED APPROXIMATELY ONE MONTH PRIOR TO THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764460 15MM POST LENGTH BASE PLATE PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. 63799890 00889024268999

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H| O SEE H11 NARRATIVE.| UNKNOWN SCREW (X2).