BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CONVERTIBLE GLENOID BASEPLATE

    MDR report key: 18245463 · Received December 1, 2023

    Report

    Report Number
    0001825034-2023-02819
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    July 26, 2023
    Report Date
    December 6, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HXX
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED FOR THE UNKNOWN BASEPLATE; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS FOR THE INITIAL SURGERY WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ROTATOR CUFF INTACT. GLENOID CONVERTIBLE BASEPLATE. ANATOMIC TOTAL SHOULDER PERFORMED WITHOUT COMPLICATIONS. INTRAOP IMAGING SHOW GOOD ALIGNMENT OF COMPONENTS. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. THE REPORTED EVENT IS NOT CONFIRMED; THE REVISION IS CONFIRMED AS PICTURES WERE PROVIDED AND PRODUCT RETURNED, HOWEVER THE OCCURRENCE OF DISASSOCIATION CANNOT BE CONFIRMED. ROOT CAUSE WAS UNABLE TO 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.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 -2023 -02267, 0001825034-2023-02012. D10: COMP CONV GLEN LINER VIVACIT-E; CAT: 110035767; LOT: 65163943; MINI TRAY STD COCR +0 OFFSET; CAT: 110031399; LOT: 65949545; VERSA-DIAL/COMP TI STD TAPER; CAT: 118001; LOT: 808600; COMP RVRS SHLDR GLNSP STD 36MM; CAT: 115310; LOT: J7505348; HMRL BEARING 36 MM STD VITE; CAT: 110031424; LOT: 65761078; VERSA-DIAL 46X18X53 HUM HEAD; CAT: 113042; LOT: J7298805; VERSA-DIAL/COMP TI STD TAPER; CAT: 118001; LOT: J7379786. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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 BEARING DISASSOCIATION APPROXIMATELY SIX MONTHS POST IMPLANTATION. 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
    1539101 UNKNOWN CONVERTIBLE GLENOID BASEPLATE SHOULDER, PROTHESIS HXX ZIMMER BIOMET, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10.