BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS TIBIAL BEARING

    MDR report key: 6709922 · Received July 13, 2017

    Report

    Report Number
    0001825034-2017-04933
    Event Type
    Injury
    Date Received
    July 13, 2017
    Date of Event
    April 25, 2017
    Report Date
    May 24, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. ALTHOUGH THE REVISION OCCURRED THERE WERE NO STATED PATIENT ADVERSE EFFECTS OR INDICATIONS FOR REVISION. 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. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS ATTRIBUTED TO A MANUFACTURING AND QUALITY SYSTEM ISSUE. RESTARTING THE MANUAL POWER WASH STATION WAS IDENTIFIED AS THE SOURCE OF THE INCREASED LEVELS OF BACTERIAL ENDOTOXIN IN THE CLEANING ENVIRONMENT. 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

    CONCOMITANT MEDICAL PRODUCTS - SIGNATURE TKA GUIDE/MODEL SET 03-05 CATALOG #: 42-422551 LOT #: 170266.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS NOT INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, [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. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). CONCOMITANT MEDICAL PRODUCTS- BIOMET SERIES A PATELLA, CATALOG # 184764, LOT # 873340. VANGUARD PS OPEN INTL LEFT FEMORAL, CATALOG # 183126, LOT # J3880165. BIOMET CC CRUCIATE TRAY 67 MM, CATALOG # 141232, LOT # J3857495.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT ALLEGES THE IMPLANT HAD HIGH ENDOTOXIN LEVELS WHICH RESULTED IN PAIN, LOSS OF MOVEMENT, RANGE OF MOTION, LOOSENING OF THE PRODUCT, ADVERSE TISSUE REACTIONS, INSTABILITY, AND INFLAMMATION. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO THESE REASONS.

    Description of Event or Problem · 1

    IT WAS REPORTED IN LITIGATION THAT THE PATIENT IS EXPERIENCING UNKNOWN DAMAGES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN INITIAL LEFT KNEE ARTHROPLASTY THE PATIENT'S BEARING WAS REVISED AT THE PATIENT'S REQUEST AFTER THE PATIENT WAS NOTIFIED THAT THE TIBIAL BEARING WAS RECALLED. PITTING AND SCRATCHING WERE NOTED AT THE REVISION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT IS NOW REPORTED FOLLOWING AN INITIAL LEFT KNEE ARTHROPLASTY, THE PATIENT'S BEARING WAS REVISED DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492521 VANGUARD PS TIBIAL BEARING PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 458510

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R| S