BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CONSTRAINED PS TIBIAL BEARING

    MDR report key: 7142052 · Received December 22, 2017

    Report

    Report Number
    0001825034-2017-11308
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    July 13, 2017
    Report Date
    April 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    (B)(4). MEDICAL PRODUCT: VANGUARD FEMORAL DISTAL AUGMENT CAT#: 184204, LOT#: 747090. VANGUARD SERIES-STANDARD PATELLA CAT #: 184764, LOT#: 986750. VANGUARD FEMORAL- RL/LM CAT #: 184184, LOT#: 046490. BIOMET SPLINED KNEE STEM V2 WITH SCREW CAT #: 148321, LOT#: 661140. BIOMET MODULAR TIBIAL AUGMENTATION BLOCK CAT #: 141763, LOT#: 222670. BIOMET MODULAR TIBIAL AUGMENTATION BLOCK CAT #: 141763, LOT#: 222670. VANGUARD SSK FEMORAL COMPONENT CAT #: 183304, LOT#: 220670. BIOMET OFFSET TIBIAL TRAY CAT #: 141483, LOT#: 482440. BIOMET OFFSET TIBIAL TRAY CAT #: 141491, LOT#: 221940. BIOMET SPLINED KNEE STEM V2 CAT#: 148308, LOT#: 978960. ULTRA DRIVE 120MM TIP EXTENDER CAT#: 148308, LOT#: 978960. ULTRA-DRIVE 9.5 SHORT OSTEOTOM CAT#: 423880, LOT#: 808270. ULTRA-DRIVE 9.5 SHORT OSTEOTOM CAT#: 423880, LOT#: 123790. THIN OSTEOTOME BLADE 8MM CAT#: 430052, LOT#: 420320. JGRKNT 2.9MM #2 BLUE MB SNGL CAT#: 912029, LOT#: P04077. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 · 1

    IT WAS FURTHER REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO POLYETHYLENE WEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED FIVE MONTHS AFTER IMPLANTATION DUE TO UNKNOWN REASONS. POLY SWAP WAS PERFORMED. REPLACEMENT BEARING AND TIBIAL LOCKING BAR WERE IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED FIVE MONTHS AFTER INITIAL KNEE PROCEDURE, ONLY BEARING WAS REPLACED DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921534 VANGUARD CONSTRAINED PS TIBIAL BEARING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 865410

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R