BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD KNEE SYSTEM CR FEMORAL LT 60

    MDR report key: 6897962 · Received September 27, 2017

    Report

    Report Number
    0001825034-2017-07264
    Event Type
    Injury
    Date Received
    September 27, 2017
    Date of Event
    August 31, 2017
    Report Date
    November 3, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK033489
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. DATE OF BIRTH (B)(6). UDI #(B)(4). CONCOMITANT MEDICAL PRODUCTS\: VNGD CR TIB BRG 10X71/75 CATALOG #183440 LOT #79820. BM ACET LP DOME SCW TI S/TAP D IA6.5X25MM CATALOG #103532 LOT #412990. BIOMET POR PRI TIB TRAY 71MM CATALOG #141263 LOT #283600. TI LOW PROFILE SCREW 6.5X20MM CATALOG #103531 LOT #380260. BIOMET FINNED PRI STEM 40MM CATALOG #141314 LOT #303390. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED,A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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 FOR THE REPORTED ISSUE IS DETERMINED TO BE PATIENT'S CONDITION. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE AND SUBSEQUENTLY WAS REVISED. PATIENT FELL ON AN UNKNOWN DATE AND IT WAS THOUGHT THAT THE PATIENT RUPTURED HER QUAD MECHANISM AND WAS REVISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A INITIAL KNEE PROCEDURE. PATIENT FELL ON AN UNKNOWN DATE AND IT WAS THOUGHT THAT THE PATIENT RUPTURED HER QUAD MECHANISM. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY FORTY-EIGHT DAYS POST-IMPLANTATION DUE TO PAIN AND LOOSENING. DURING THE REVISION PROCEDURE, THE SURGEON NOTED THE PATIENT HAD LACK OF BONY INGROWTH ON THE IMPLANTS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676940 VANGUARD KNEE SYSTEM CR FEMORAL LT 60 PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 251330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R