BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAS PSI KNEE SYSTEM

    MDR report key: 5885392 · Received August 18, 2016

    Report

    Report Number
    0009617840-2016-00024
    Event Type
    Injury
    Date Received
    August 18, 2016
    Date of Event
    September 11, 2014
    Report Date
    May 19, 2015
    Manufacturer
    ZIMMER CAS
    Product Code
    OOG
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE OOG. IT WAS REPORTED BY THE SALES REP THAT ON THE SIX MONTH POST-OP FOLLOW UP, THE PATIENT HAD A HKA OF 12 DEGREES VALGUS. MULTIPLE ATTEMPTS TO OBTAIN A STANDING LONG LEG X-RAY FROM THE SURGEON FOR EVALUATION WERE UNSUCCESSFUL. NO ADDITIONAL INFORMATION IS AVAILABLE FOR FURTHER INVESTIGATION OF THIS EVENT. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THE SURGEON STATED THAT ON THE SIX MONTH POST-OP FOLLOW UP, THE PATIENT HAD A HIP-KNEE-ANKLE (HKA) ALIGNMENT OF 12 DEG VALGUS. MULTIPLE ATTEMPTS WERE MADE TO CONFIRM THE OUTCOME, BUT, WITHOUT SUCCESS. IT IS NOT KNOWN IF ANY ADDITIONAL MEDICAL INTERVENTION WAS UNDERTAKEN TO CORRECT THE PATIENT'S POST-OP CONDITION, AND NO ADDITIONAL INFORMATION IS AVAILABLE FOR FURTHER INVESTIGATION OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538907 CAS PSI KNEE SYSTEM KNEE ARTHROPLASTY IMPLANTATION SYSTEM OOG ZIMMER CAS N/A TRA1B7L46MM14US

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other