BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 2063717 · Received April 14, 2011

    Report

    Report Number
    1822565-2011-00957
    Event Type
    Injury
    Date Received
    April 14, 2011
    Report Date
    March 18, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRE-OP AND POST-OP X-RAYS ARE NOT AVAILABLE TO ANALYZE THE FIXATION ALTHOUGH THE SURGEON MENTIONS THAT THE X-RAYS WERE NORMAL. PT DEMOGRAPHICS EXCEPT FOR DATE OF BIRTH ARE ALSO UNAVAILABLE. HOWEVER, SURGICAL NOTES PROVIDED INDICATE THAT THERE WAS QUADRICEPS INSUFFICIENCY WHICH WAS RECTIFIED DURING THE SURGERY. THE PRODUCTS USED FOR IMPLANTATION ARE IN PROPER COMBINATION. THE FEMORAL COMPONENT USED FOR IMPLANTATION CONTAINS SMALL AMOUNT OF NICKEL. ALLERGY TESTING SHOWED THAT THE PT IS ALLERGIC TO NICKEL BUT PT'S PAIN CANNOT BE DIRECTLY ATTRIBUTED TO THIS ALLERGY. WITH THE AVAILABLE INFO, THE PROBABLE CAUSE FOR PT'S PAIN IN THE KNEE CANNOT BE DEFINITIVELY DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT EXPERIENCED PAIN SINCE SURGERY AND HAD AN ALLERGY TEST THAT SHOWED A REACTION TO NICKEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC. 61204344

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MFG. AT ZIMMER (B)(4)| NEXGEN COMPLETE KNEE SOLUTION STEMMED TIBIAL| COMPONENT: CAT # 00576401651, LOT # 61268048| NEXGEN COMPLETE KNEE SOLUTION TAPER STEM PLUG:| POSTERIOR STABILIZED LPS-FLEX GSF FEMORAL| NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-| CAT #00596009900,LOT #61257189, MFG. AT ZIMMER| COMPONENT: CATALOG # 00598003702, LOT# 61263956,