BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LEGACY LPS ARTICULAR SURFACE

    MDR report key: 2630657 · Received June 22, 2012

    Report

    Report Number
    1822565-2012-01320
    Event Type
    Injury
    Date Received
    June 22, 2012
    Report Date
    May 23, 2012
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS UNK ON WHICH DATE THE ASPIRATION TOOK PLACE. SURGICAL NOTES INDICATE THAT THE ASPIRATION DID NOT INDICATE INFECTION OR ANY POSSIBLE ROOT CAUSE FOR THE PT'S PAIN. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. 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. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. 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 UNDERWENT AN ASPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LEGACY LPS ARTICULAR SURFACE JWH ZIMMER INC 60691055

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATALOG #00599603801, LOT #60934265| (B)(4)| NEXGEN ALL POLY PATELLA: CATALOG #00597206532,| NEXGEN STEMMED TIBIAL COMPONENT:| LOT #60908807| LOT #60927223, MANUFACTURED AT ZIMMER (B)(4)| NEXGEN LPS FEMORAL COMPONENT: CATALOG #00599601551