BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-KNEE II STEMMED TIBIAL BASEPLATE

    MDR report key: 2841928 · Received November 14, 2012

    Report

    Report Number
    1822565-2012-02331
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    March 2, 2012
    Report Date
    October 15, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ZIMMER STERILIZATION VENDOR PROCESSES ALL IMPLANTS TO MEET FDA REGULATIONS AND ISO STANDARDS AT A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10-6 OR BETTER. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. NEITHER SURGICAL NOTES NOR X-RAYS WERE PROVIDED, THEREFORE, FIT AND ORIENTATION COULD NOT BE EVALUATED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION CODES: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED LOOSENING AND PAIN, AND UNDERWENT A TWO-STAGE REVISION. DURING REVISION, 1+ GRAM POSITIVE COCCI WAS NOTED. THE SURGEON NOTED EXTENSIVE DEBRIDEMENT OF OSTEOLYSIS AND INFLAMED SYNOVIUM. SECOND STAGE WAS PERFORMED ON (B)(6) 2012. THE SURGEON NOTED THAT THE PATIENT HAD SUSTAINED CATASTROPHIC LEFT KNEE POLYETHYLENE FAILURE WITH OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE II STEMMED TIBIAL BASEPLATE JWH ZIMMER, INC. 60884134

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention CATALOG #621200040, LOT #60888421| NATURAL-KNEE II ULTRA CONGRUENT TIBIAL INSERT:| CATALOG #627502613, LOT #1634575| NATURAL-KNEE II ALL POLY PATELLA:| CATALOG #630007102, LOT #61071236| NATURAL-KNEE II SINTERLOCK FEMORAL COMPONENT: