BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINN ROTATING HINGED KNEE AXLE

    MDR report key: 6836274 · Received August 31, 2017

    Report

    Report Number
    0001825034-2017-06795
    Event Type
    Injury
    Date Received
    August 31, 2017
    Report Date
    December 12, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK910877
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIVING ADDITIONAL INFORMATION ON THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THE X-RAYS REVEALED FEMORAL LOOSENING AND OSTEOLYTIC LESION OF THE PROXIMAL TIBIAL COMPONENT.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: CATALOG #: 153986, FINN ROTATING HINGED KNEE MODULAR TIBIAL BEARING, LOT # 374460. CATALOG #: CP111012, FINN ROTATING HINGED KNEE FEMORAL STEM, LOT # 399340. CATALOG #: 153803, FINN ROTATING HINGED KNEE MODULAR SEGMENTAL FEMORAL RIGHT, LOT # 506660. CATALOG #: CP111134, FINN ROTATING HINGED KNEE TIBIAL BASE, LOT # 137000. CATALOG #: 11-150826, BIOMET ARCOM ALL POLYETHYLENE BUTTON, LOT # 863040. CATALOG #: 153861, FINN ROTATING HINGED KNEE LOCK PIN, LOT # 874840. CATALOG #: 153865, FINN ROTATING HINGED KNEE YOKE STANDARD REINFORCED, LOT # 642660. CATALOG #: 153851, FINN ROTATING HINGED KNEE TIBIAL BUSHING, LOT # 938960. CATALOG #: 153852, FINN ROTATING HINGED KNEE FEMORAL BUSHING, LOT # 587230. THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION OR NOT. ONCE THIS INFORMATION IS OBTAINED A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-06779, 06790, 06791, 06792, 06793, 06794, 06927, 06928 AND 06929.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND IS BEING REVISED FOR UNKNOWN REASONS ON AN UNKNOWN DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614456 FINN ROTATING HINGED KNEE AXLE PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS N/A 837890

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R