BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SMOOTH KNEE STEM

    MDR report key: 7068699 · Received November 29, 2017

    Report

    Report Number
    0001825034-2017-10677
    Event Type
    Injury
    Date Received
    November 29, 2017
    Report Date
    January 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE AS THIS PRODUCT WAS NOT RELATED TO THE PATELLA FRACTURE AND PAIN OF THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - ARCOM SERIES A PATELLA STANDARD # 184764 LOT # 535310, BIOMET OFFSET TIBIAL TRAY # 141482 LOT # 744940, VANGUARD PS TIBIAL BEARING # 183624 LOT # 653110, BIOMET OFFSET TIBIAL TRAY ADAPTOR # 141491 LOT # 470640. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-10674, 0001825034-2017-10675, 0001825034-2017-10676 AND 0001825034-2017-10678. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND LOSS OF SENSATION IN HIS LEFT KNEE POST A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848324 BIOMET SMOOTH KNEE STEM PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 574960 

    Patients

    Seq Age Sex Outcome Treatment
    1 Other