BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE SYSTEM - TIBIAL BRG 16X71

    MDR report key: 6396790 · Received March 10, 2017

    Report

    Report Number
    0001825034-2017-01493
    Event Type
    Injury
    Date Received
    March 10, 2017
    Date of Event
    February 9, 2017
    Report Date
    October 19, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). (B)(4). CONCOMITANT PRODUCTS: BIOMET REGENEREX TIBIAL TRAY 71MM CATALOG 141273 LOT 091570;BIOMET FINNED STEM 40MM CATALOG 141314 LOT 465480; VANGUARD RIGHT FEMUR 70MM CATALOG 167032 LOT 3850747; SERIES A PATELLA CATALOG 184700 LOT 279760. REPORT SOURCE: (B)(6) CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-01492 AND 0001825034-2017-01494.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. 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 UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY THREE MONTHS POST IMPLANTATION DUE TO LOOSENING CAUSED BY MEDIAL COLLATERAL LIGAMENT DAMAGE. THE TIBIAL TRAY, STEM, AND BEARING WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176549 VANGUARD COMPLETE KNEE SYSTEM - TIBIAL BRG 16X71 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 663750

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R SEE H10 NARRATIVE