BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD FEMORAL COMPONENT

    MDR report key: 6897371 · Received September 27, 2017

    Report

    Report Number
    0001825034-2017-07406
    Event Type
    Injury
    Date Received
    September 27, 2017
    Date of Event
    August 24, 2017
    Report Date
    January 5, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: BCM-UNKNOWN-UNK, KNE-VANGUARD SSK-TIBIAL TRAYS-UNK, KNE-VANGUARD SSK-STEMS-UNK. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED, WHICH DEMONSTRATE A PERIPROSTHETIC LUCENCY SURROUNDING THE DISTAL FEMORAL STEM SUGGESTING LOOSENING/INFECTION. VISUAL INSPECTION OF THE HARDENED BONE CEMENT ON THE FEMORAL ASSEMBLY IDENTIFIED ABSENCE OF BONE ADHESION ON TO THE BONE CEMENT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT 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 · 1

    (B)(4). MEDICAL PRODUCT: VANGUARD TIBIAL BEARING, CAT#: 183820 LOT#: 032230. VANGUARD DISTAL FEMORAL AUGMENT, CAT#: 184200 LOT#: 581650. BIOMET SPLINED STEM, CAT#: 141654 LOT#: 336580. VANGUARD POSTERIOR FEMORAL AUGMENT, CAT#: 184140 LOT#: 222340. VANGUARD DISTAL FEMORAL AUGMENT, CAT#: 184180 LOT#: UNKNOWN. REPORT SOURCE:(B)(6). 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.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS FEMORAL LOOSENING AND OSTEOLYSIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS FEMORAL LOOSENING AND OSTEOLYSIS. IT WAS NOTED THAT THE PATIENT HAD A VERY SCLEROTIC FEMORAL CANAL AND DEFICIENT CONDYLAR REGION WHICH CONTRIBUTED TO THE NEED OF A REVISION PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677554 VANGUARD FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 306570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R