BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD FEMORAL POSTERIOR AUGMENT

    MDR report key: 7451334 · Received April 23, 2018

    Report

    Report Number
    0001825034-2018-02938
    Event Type
    Injury
    Date Received
    April 23, 2018
    Date of Event
    September 15, 2017
    Report Date
    April 20, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS- 185100 NAME: VNGD SSK PS TIB BRG 10X79/83 LOT: 539800, 141656 NAME: BMT SPLINED KNEE STM 16X120 LOT: 645660, 183326 NAME: VNGD SSK INTLK FMRL 70 LT LOT: 181120, 184166 NAME: VNGD POST FEM AUG 70X5 LL/RM LOT: 668840, 184126 NAME: VNGD DIST FEM AUG 70X5 LL/RM LOT: 897770, 184146 NAME: VNGD POST FEM AUG 70X5 RL/LM LOT: 854490, 141516 NAME: BIOMET ILOK STEM TIB TRAY 83MM LOT: 081270, 184607 NAME: RGX CONE AUG POR TI 40MM MED LOT: 004300, 141652 NAME: BMT SPLINED KNEE STM 12X120 LOT: 992860. REPORTED EVENT WAS CONFIRMED THROUGH RADIOGRAPHS RECEIVED. PRODUCT WAS NOT RETURNED FOR EVALUATION. X-RAY REVIEW REPORT INDICATES PRESENCE OF LUNCENCY SURROUNDING THE FEMORAL STEM. OSTEOPENIA. NORMAL ANATOMY. NO FRACTURE SEEN. NO EVIDENCE OF WEAR OR DEBRIS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-08332-2, 0001825034-2017-08334-2, 0001825034-2017-08335-2, 0001825034-2018-02937, 0001825034-2018-02938.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN, OSTEOLYSIS AND LOOSENING OF THE STEM AND FEMORAL. THE POLYETHYLENE BEARING ALSO SHOWED SIGNS OF PITTING AND WEAR DURING THE REVISION PROCEDURE. ADDITIONALLY, THERE WAS A SLIGHT DELAY IN PROCEDURE DURING THE REVISION TO REPAIR A FRACTURE THAT WAS PRESENT DUE TO BONE LOSS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293483 VANGUARD FEMORAL POSTERIOR AUGMENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 854490

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R