BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP CONV GLEN LINER VIVACIT-E

    MDR report key: 17611212 · Received August 24, 2023

    Report

    Report Number
    0001825034-2023-02012
    Event Type
    Injury
    Date Received
    August 24, 2023
    Date of Event
    July 26, 2023
    Report Date
    December 6, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED WEAR AND DAMAGE NOTICED ON RADIUS AND SIDE BY HASH MARKS AND UNDERNEATH POSTS NEAR TAPER. PRODUCT IDENTIFIER MEASUREMENT WAS TAKEN AND WAS WITHIN TOLERANCE. PART AND LOT NUMBERS CONFIRMED. 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 WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 D10: 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. 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.

    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
    271455 COMP CONV GLEN LINER VIVACIT-E SHOULDER, PROSTHESIS HXX ZIMMER BIOMET, INC. 65163943

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10.