BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    MDR report key: 4275215 · Received November 7, 2014

    Report

    Report Number
    3007963827-2014-00059
    Event Type
    Injury
    Date Received
    November 7, 2014
    Report Date
    August 13, 2014
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED ON THIS FORM WAS PREVIOUSLY SUBMITTED UNDER MFR REPORT NUMBER: 1822565-2014-011. EVALUATION SUMMARY: 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 INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. A PRODUCT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINT FOR THE IMPLANTED COMPONENTS. OF THESE IMPLANTS, ONLY THE FEMORAL COMPONENT CONTAINS NICKEL. NO FURTHER INFORMATION REGARDING THE REPORTED IMPLANT FAILURE WAS RECEIVED. AT THIS TIME, THE TYPE OF FAILURE CANNOT BE DETERMINED AND IT IS UNKNOWN WHICH COMPONENTS WERE INVOLVED. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING A POSSIBLE ALLERGIC REACTION AND IMPLANT FAILURE. THE NATURE OF THE FAILURE IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717142 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT JWH ZIMMER 62211151

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE| ZIMMER (B)(4)| CATALOG#: 00598003701, LOT# 62197406| ZIMMER (B)(4)| NEXGEN STEMMED PRECOAT TIBIAL PLATE| CATALOG: 00596203212, LOT #32160322