BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-KNEE ARTRICULAR SURFACE

    MDR report key: 2030639 · Received March 18, 2011

    Report

    Report Number
    1822565-2011-00679
    Event Type
    Injury
    Date Received
    March 18, 2011
    Report Date
    November 4, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT) ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: 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. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING LOW RANGE OF MOTION, TIGHTNESS, AND PAIN. SHE HAD MANIPULATION 6 WEEKS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE ARTRICULAR SURFACE JWH ZIMMER, INC. 61023689

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other GENDER SOLUTIONS NATURAL-KNEE SYSTEM PROLONG,| LOT #60975439| GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMAL| LOT #61205537| CATALOG #00510000801, LOT #61204778| FEMORAL COMPONENT, CATALOG #630700200 ,| (GSF) FEMORAL COMPONENT, CATALOG #00541401401,| NATURAL-KNEE SYSTEM II STEMMED FEMAIL (GSF)