BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINN ROTATING HINGED KNEE TIBIAL BASE

    MDR report key: 6836221 · Received August 31, 2017

    Report

    Report Number
    0001825034-2017-06793
    Event Type
    Injury
    Date Received
    August 31, 2017
    Report Date
    January 6, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PCUSTOM
    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

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. THE REPORTED EVENT WAS CONFIRMED THROUGH RADIOGRAPHIC INSPECTION. EVALUATION IS LIMITED BY ONLY A SINGLE POOR QUALITY CORONAL CT IMAGE OF THE KNEE IS SUBMITTED FOR REVIEW. THE X-RAY REVIEW PERFORMED REVEALS THAT THERE ARE APPARENT CRACKS WITHIN THE FEMORAL STEM CEMENT MANTLE AND RADIOLUCENCIES AT FEMORAL STEM METAL-CEMENT INTERFACES, SUGGESTING LOOSENING OF THE FEMORAL STEM. THERE IS A POSSIBLE ABSCESS/OSTEOLYSIS CORTEX OF THE MID-DISTAL FEMORAL SHAFT. AN OSTEOLYTIC LESION OF THE PROXIMAL TIBIAL SUBJACENT TO THE LATERAL TIBIAL TRAY IS SUSPECTED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DEVIATIONS RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A COMPLAINT HISTORY SEARCH WAS PERFORMED AND NO ACTIONS ARE REQUIRED. LOOSENING OF THE FEMORAL STEM AND OSTEOLYSIS AROUND THE TIBIAL TRAY HAS BEEN CONFIRMED BY X-RAY REVIEW, HOWEVER, IT IS UNKNOWN WHAT CAUSED LOOSENING AND OSTEOLYSIS. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    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 #: 11-150826, BIOMET ARCOM ALL POLYETHYLENE BUTTON, LOT # 863040. CATALOG #: 153861, FINN ROTATING HINGED KNEE LOCK PIN, LOT # 874840. CATALOG #: 153872, FINN ROTATING HINGED KNEE AXLE, LOT # 837890. 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, 06794, 06795, 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616912 FINN ROTATING HINGED KNEE TIBIAL BASE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 137000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R