BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE SYSTEM - PS TIBIAL BEARING 10X63/67MM

    MDR report key: 6421047 · Received March 21, 2017

    Report

    Report Number
    0001825034-2017-01756
    Event Type
    Injury
    Date Received
    March 21, 2017
    Date of Event
    February 21, 2017
    Report Date
    April 11, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY INVESTIGATION RESULTS. 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 COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 FLED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). (B)(4). MEDICAL PRODUCTS - CT SIG TKA GDE/MDL SET 04-05 CATALOG# 42-422566 LOT# 169057, BMET REGENX PRI TIB TRAY 67 MM CATALOG# 141272 LOT# 185920, BIOMET I-BEAM PRI STEM 40 MM CATALOG# 141310 LOT# 024410, VANGUARD PS POR FEM - RT 65 CATALOG# 184508 LOT# 881250. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ONE MONTH POST-IMPLANTATION DUE TO INFECTION. THE POLYETHYLENE BEARING WAS REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203413 VANGUARD COMPLETE KNEE SYSTEM - PS TIBIAL BEARING 10X63/67MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 224520

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R