BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD INTRAMEDULLARY PLUG XL

    MDR report key: 19604399 · Received June 25, 2024

    Report

    Report Number
    0001825034-2024-01672
    Event Type
    Injury
    Date Received
    June 25, 2024
    Report Date
    July 10, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDS
    UDI-DI
    00880304227354
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS COMPLAINT FILE UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (B)(4) 0001825034-2024-01818. 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). D10: 00542000800 - ALL POLY PATELLA SIZE 0 8 MM THICKNESS - 64212622. 00585204025 - STEM COLLAR 25 MM O.D. FOR USE WITH 16 MM OR SMALLER DIAMETER SEGMENTAL STEMS - 64243673. 5036964 - HERAEUS MEDICAL CEMENT W/GENT HIGH VISCOCITY - 93564861. 183302 - VNGD SSK PSC INTLK FMRL 60 RT - 605140. 183824 - VNGD SSKPSC TIB BRG S 14X63/67 - 636650. 185201 - BMT 360 TIB TRAY 63MM - 897880. 148162 - BMT GB KNEE STM 12X80 - 153050. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR 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 UNDERWENT A KNEE SURGERY AND APPROXIMATELY 3 MONTHS POST-OP, THE PATIENT WAS DIAGNOSED WITH PATELLAR TENDONITIS AND RECEIVED A STEROID INJECTION. THE PATIENT CONTINUED TO HAVE ONGOING ISSUES WITH PAIN, SWELLING, QUADRICEP WEAKNESS/ATROPHY, BALANCE DEFICITS, AND LIMITED RANGE OF MOTION. ADDITIONAL COURSES OF PHYSICAL THERAPY WERE PRESCRIBED WITHOUT RESOLUTION. THE PATIENT DOES NOT WANT TO UNDERGO ANOTHER REVISION AND HAS CONTINUED TO SEEK HELP FOR ONGOING SYMPTOMS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172911 VANGUARD INTRAMEDULLARY PLUG XL PROSTHESIS, KNEE JDS ZIMMER BIOMET, INC. N/A 685630 00880304227354

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other