BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN GSF CR-FLEX FEMORAL COMPONENT

    MDR report key: 2706302 · Received August 16, 2012

    Report

    Report Number
    3007963827-2012-00009
    Event Type
    Injury
    Date Received
    August 16, 2012
    Report Date
    July 20, 2012
    Manufacturer
    ZIMMER ORTHOPEDIC MFG LTD
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER SURGICAL NOTES NOR X-RAYS WERE PROVIDED, THEREFORE FIT AND ORIENTATION COULD NOT BE EVALUATED. 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 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. SHOULD ADD¿L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT EXPERIENCED PAIN IN HER RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN GSF CR-FLEX FEMORAL COMPONENT JWH ZIMMER ORTHOPEDIC MFG LTD 61488050

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MANUFACTURED AT ZIMMER (B)(4)| NEXGEN PROLONG CR ARTICULAR SURFACE:| NEXGEN CR PEGGED TIBIAL COMPONENT:| CAT # 00595202110, LOT # 61579282| MANUFACTURED AT ZIMMER (B)(4)| CAT #00597206629, LOT # 61532637| NEXGEN PROLONG ALL POLY PATELLA:| CAT # 00597002501, LOT # 61424941| MANUFACTURED AT ZIMMER (B)(4)