BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPR RVS GLENO 2-PRNG INS/IMP

    MDR report key: 21833888 · Received April 14, 2025

    Report

    Report Number
    0001825034-2025-01077
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Report Date
    September 2, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K193373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: CANADA H3: CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. H6: COMPONENT CODES: MECHANICAL (G04) - IMPACTOR 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 AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2; H3; H6. THE FOLLOWING SECTION WAS CORRECTED: D9. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE ITEM DOES HAVE A CRACK IN THE BLACK RADEL TIP. THERE IS SOME MINOR DAMAGE TO THE DISTAL TIP AREA ALONG WITH SOME WEAR ON THE KNURLED PORTIONS. THE STRIKE PLATE SHOWS THAT THERE IS HEAVY DAMAGE TO IT. THE APPROXIMATE FIELD AGE OF THE INSTRUMENT IS 6 YEARS OLD. DIMENSIONS WHERE MEASURED ARE IN SPECIFICATION. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 THE TIP OF THE INSTRUMENT WAS CRACKED. ATTEMPTS HAVE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022724 COMPR RVS GLENO 2-PRNG INS/IMP SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 204520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown