BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 3031984 · Received March 28, 2013

    Report

    Report Number
    2648920-2013-00087
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    May 20, 2008
    Report Date
    February 27, 2013
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: REVIEW OF PRIMARY SURGICAL REPORT PROVIDED DID NOT REVEAL INDICATIONS THAT THE RECOMMENDED SURGICAL TECHNIQUE WAS NOT FOLLOWED. THE REVISION SURGICAL REPORT STATES THAT THE TIBIAL IMPLANT HAD SUBSIDED INTO MEDIAL CANCELLOUS BONE. NO X-RAYS WERE RECEIVED, SO NO CHECK COULD BE MADE FOR CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: MANUFACTURING DOCUMENTATION FOR THE TIBIAL COMPONENT WAS REVIEWED AND INDICATES THAT IT WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION. 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 IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129070 NEXGEN STEMMED TIBIAL COMPONENT JWH ZIMMER MANUFACTURING B.V. 60615630

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention PALACOS R+G BONE CEMENT: CATALOG #00111314001| SURGICAL PRODUCTS| THIS BONE CEMENT IS MANUFACTURED AT HERAEUS| MEDICAL AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC| LOT #65234095