BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 75MM

    MDR report key: 8842949 · Received July 30, 2019

    Report

    Report Number
    0001825034-2019-03306
    Event Type
    Injury
    Date Received
    July 30, 2019
    Report Date
    July 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # EP-183440 LOT # 192970, ITEM # 183032 LOT # 633940. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-10726, 0001825034-2018-10725. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. SURGICAL NOTES WERE NOT PROVIDED. PATIENT WAS REPORTED TO HAVE METAL ALLERGY AND COULD BE A CONTRIBUTING CONDITION . HOWEVER, ROOT CAUSE CANNOT BE DETERMINED. 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 PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY SUBSEQUENTLY THE PATIENT UNDERWENT A PROCEDURE TO REMOVE SCAR TISSUE DUE TO PAIN AND LIMITED RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638182 BIOMET CC CRUCIATE TRAY 75MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J3081730

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R