BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURAL-KNEE II SYSTEM POROUS COATED REVISION TIBIAL BASEPLATE

    MDR report key: 1214107 · Received October 24, 2008

    Report

    Report Number
    1822565-2008-00730
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: REVISION TIBIAL BASEPLATES WERE ATTEMPTED TO BE USED WITH PRODUCT LINE CCK ARTICULAR SURFACE WHICH ARE NOT COMPATIBLE. EVALUATION: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE RE-OPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DR. WAS DOING A REVISION KNEE BECAUSE ON THE TIBIA WAS SIZE BEST FOR A "00". HIS PATIENT NEEDED A NATURAL KNEE CCK FEMUR FOR STABILITY. HE HAD BEEN INFORMED THAT THE "00" TIBIA COULD BE USED WITH A CCK INSERT. THAT WAS NOT THE CASE. THE "00" REVISION TIBIA WAS NOT CONVERTED TO ACCEPT THE CCK INSERT LIKE ALL THE OTHER REVISION TIBIAS (0-4) SIZES. THIS CAUSED THE FEMORAL IMPLANTS TO BE WASTED, SINCE THE PATIENT NEEDED A TIMELY SURGERY. THE SURGERY WAS DELAYED TILL THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE II SYSTEM POROUS COATED REVISION TIBIAL BASEPLATE KNEE PROSTHESIS HSH ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR