BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE SYSTEM BEARING

    MDR report key: 6710012 · Received July 13, 2017

    Report

    Report Number
    0001825034-2017-04900
    Event Type
    Injury
    Date Received
    July 13, 2017
    Date of Event
    June 8, 2017
    Report Date
    October 5, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: REGENEREX TIBIAL COMPONENTS, CAT#: 141276 LOT#: 627520, REGENEREX TIBIAL COMPONENTS, CAT#: 141369 LOT#: 300080, VANGUARD COMPLETE KNEE SYSTEM, CAT#: 183053 LOT#: 564400, VANGUARD PATELLA COMPONENTS, CAT#: 184770 LOT#: 473790. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, [PRODUCT LOCATION UNKNOWN AT THIS TIME]. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04896, 0001825034-2017-04897, 0001825034-2017-04898, 0001825034-2017-04899, 0001825034-2017-04900. H3 OTHER TEXT : PRODUCT LOCATION UNKNOWN.

    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. THE SURGEON STATED A COMPETITOR'S WRIST PLATE WAS THE SOURCE OF INFECTION. 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 WAS REVISED, ELEVEN MONTHS AFTER INITIAL IMPLANTATION, DUE TO AN INFECTION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490690 VANGUARD COMPLETE KNEE SYSTEM BEARING PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 453860

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R SEE H10 NARRATIVE