BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    MDR report key: 2926396 · Received January 16, 2013

    Report

    Report Number
    1822565-2013-00101
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    May 15, 2009
    Report Date
    December 17, 2012
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: REVIEW OF IMPLANTATION, AND MANIPULATION SURGICAL REPORTS PROVIDED GIVES NO INDICATIONS OF A ROOT CAUSE. NO X-RAYS WERE REC'D, SO NO CHECK COULD BE MADE FOR CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PT 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 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. 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 ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT UNDERWENT MANIPULATION UNDER ANESTHESIA DUE TO RIGHT KNEE ARTHROFIBROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23649 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT JWH ZIMMER INC 61174009

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention LOT #61150272| NEXGEN STEM EXTENSION, CATALOG #00598801813,| NEXGEN STEMMED TIBIAL COMPONENT,| PONCE, PUERTO RICO| THE FOLLOWING WERE MANUFACTURED AT ZIMMER BV,| CATALOG #00596403017, LOT #61116102| NEXGEN LPS-FLEX ARTICULAR SURFACE,| CATALOG #00598003701, LOT #61166845