BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS SEAS HMRL HEAD 40X15

    MDR report key: 17548430 · Received August 15, 2023

    Report

    Report Number
    0001825034-2023-01886
    Event Type
    Injury
    Date Received
    August 15, 2023
    Date of Event
    July 19, 2023
    Report Date
    October 24, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    UDI-DI
    00880304540828
    PMA / PMN Number
    K223631
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PROPOSED CODE: MECHANICAL (G04)- HEAD. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO USE ERROR AS IN THE INITIAL NOTIFICATION THE SALES REPRESENTATIVE INQUIRED WITH DEVELOPMENT IF IT WAS POSSIBLE FOR THE HEADS TO BE INSTALLED BACKWARDS. AFTER FOLLOW UP, THE REPRESENTATIVE INDICATED THE PRODUCTS WERE INCORRECTLY INSTALLED. THE REPORTED EVENT IS UNCONFIRMED. 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: COMPR SRS TUMOR BDY - 71MM CAT: 211223, LOT: 920260. 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

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-01887. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. H3 OTHER TEXT : PRODUCT NOT RETURNED.

    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 WAS REVISED DUE TO IMPLANT DISASSOCIATION DUE TO MISASSEMBLY AT IMPLANTATION APPROXIMATELY SEVEN MONTHS POST IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS BEEN INDICATED FOR A REVISION DUE TO IMPLANT DISASSOCIATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245864 COMPR SRS SEAS HMRL HEAD 40X15 SHOULDER, PROSTHESIS JDC ZIMMER BIOMET, INC. 038830 00880304540828

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other SEE H10.| UNKNOWN TUMOR BODY.