BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 75MM

    MDR report key: 6661603 · Received June 22, 2017

    Report

    Report Number
    0001825034-2017-04223
    Event Type
    Injury
    Date Received
    June 22, 2017
    Date of Event
    February 23, 2017
    Report Date
    September 1, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE CMP-(B)(4) MEDICAL PRODUCTS- VANGUARD PS CLOSED INTERLOK FEMORAL-LEFT 67.5, ITEM # 183230, LOT # 890980. VANGUARD PS TIBIAL BEARING 10X71/75, ITEM # 183740, LOT # 672130. AGC PATELLA ARCOM POLY WITH WIRE 34MM, ITEM # 11-150828, LOT # 509440. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO THE DEVICE BEING DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2017-04220.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING AN INITIAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO FEMORAL LOOSENING. THE TIBIA WAS IN VARUS ALIGNMENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441951 BIOMET CC CRUCIATE TRAY 75MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 529610

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10