BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPICCI II UNICONDYLAR KNEE - REPICCI FMRL 54MM RM/LL

    MDR report key: 6574858 · Received May 18, 2017

    Report

    Report Number
    0001825034-2017-03334
    Event Type
    Injury
    Date Received
    May 18, 2017
    Report Date
    August 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRY
    PMA / PMN Number
    PK971938
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: REPICCI TIBA, CATALOG 102150, LOT 235940; COBALT BONE CEMENT, CATALOG 402283, LOT 292850. CUSTOMER HAS NOT INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. BASED ON THE INFORMATION AVAILABLE, ROOT CAUSE WAS DETERMINED TO BE THE PATIENT'S CONDITION - PATIENT HAS PATELLA ALTA. 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 HAS BEEN INDICATED FOR A REVISION OF A PARTIAL KNEE PROSTHESIS DUE TO UNKNOWN REASONS. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356064 REPICCI II UNICONDYLAR KNEE - REPICCI FMRL 54MM RM/LL PROSTHESIS, KNEE HRY BIOMET ORTHOPEDICS 549350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention