BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MODULAR TIBIAL I-BEAM STEM 40MM

    MDR report key: 6843166 · Received September 5, 2017

    Report

    Report Number
    0001825034-2017-06943
    Event Type
    Injury
    Date Received
    September 5, 2017
    Report Date
    September 10, 2018
    Manufacturer
    .
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-06944, 0001825034-2017-06945, 0001825034-2017-06946, 0001825034-2017-06967. CONCOMITANT MEDICAL PRODUCTS: ¿ VANGUARDFEMORAL COMPONENT CATALOG # CP113637 LOT # 728910. BIOMET ILOCK TIBIAL RAY CATALOG # 141212 LOT # 429950. VANGUARD TIBIAL BEARING CATALOG # 183620 LOT # 522350. BIOMET ARCOM PATELLA CATALOG # 184786 LOT # 963860. COBALT MV BONE CEMENT 40GM B CATALOG # 402438 LOT # 247470. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED,A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY THE PATIENT IS EXPERIENCING SHARP PAIN AROUND THE PATELLA, UP THE THIGH AND STIFFNESS. THE PATIENT IS SCHEDULED FOR REVISION ON AN UNKNOWN DATE. NO ADDITIONAL PATIENT CONSEQUENCE WAS REPORTED. 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
    621900 BIOMET MODULAR TIBIAL I-BEAM STEM 40MM PROSTHESIS, KNEE JWH . N/A 438210

    Patients

    Seq Age Sex Outcome Treatment
    1 Other