BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 3192009 · Received June 20, 2013

    Report

    Report Number
    2648920-2013-00134
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    January 7, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNK. 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 AVAILABLE INFORMATION, 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 IS REPORTED THAT THE PT WAS REVISED DUE TO TIBIAL COMPONENT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281042 NEXGEN STEMMED TIBIAL COMPONENT JWH ZIMMER 60446262

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention LOT #60457751, MFG AT ZIMMER INC, (B)(4)| CAT # 00597206532, LOT #60475788,| PALACOS R BONE CEMENT: CAT #00111214001| DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC SURGICAL| LOT #63443904, MFG AT HERAEUS MEDICAL| NEXGEN LPS-FLEX FEMORAL COMPONENT: CAT#00596401651| NEXGEN ALL POLY PATELLA: