BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-KNEE SYSTEM CONGRUENT TIBIAL INSERT

    MDR report key: 2263045 · Received September 20, 2011

    Report

    Report Number
    1822565-2011-02111
    Event Type
    Injury
    Date Received
    September 20, 2011
    Date of Event
    June 6, 2011
    Report Date
    August 23, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNK. NEITHER SURGICAL NOTES NOT X-RAYS WERE PROVIDED, THEREFORE FIT AND ORIENTATION COULD NOT BE EVALUATED. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT) ARE UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS FOR THE INSERT DID NOT FIND ANY DEVIATIONS OR ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PATELLA WAS NOT POSSIBLE AS THE LOT NUMBER REQUIRED FOR RETRIEVAL WAS 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 INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT'S KNEE HAD LOOSENED OVER TIME DUE TO POLY WEAR. SURGERY WAS PERFORMED TO REPLACE OLD NKI INSERT AND PATELLA. OTHER IMPLANTS WERE WELL-FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE SYSTEM CONGRUENT TIBIAL INSERT JWH ZIMMER, INC. 1216158

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention COMPONENT: CAT#620001101, LOT#UNK| NATURAL-KNEE II SYSTEM METAL BACKED PATELLA