BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    MDR report key: 2843442 · Received November 15, 2012

    Report

    Report Number
    1822565-2012-02351
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    June 3, 2011
    Report Date
    February 21, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: 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. EVAL: 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 ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT: CATALOG #00595003701, NEXGEN MIS STEMMED TIBIAL COMPONENT, LOT #60352909. REVIEW OF PRIMARY SURGICAL REPORT PROVIDED DID NOT REVEAL ANY DEVIATIONS FROM THE SURGICAL TECHNIQUE. THE REVISION SURGICAL REPORT STATED THAT THE TIBIAL COMPONENT HAD GROSS MOTION AND THE FEMORAL COMPONENT HAD LARGE GAPS BETWEEN THE IMPLANT AND CEMENT AS WELL AS BONE; THE LATERAL COLLATERAL LIGAMENT WAS NOTED TO BE VERY LOOSE. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED NICKS AND GOUGES ON THE RETURNED DEVICES. THE FEMORAL COMPONENT HAD BONE CEMENT REMAINING ON THE MEDIAL SIDE OF THE BACKSIDE. THE ARTICULAR SURFACE EXHIBITED SIGNS OF WEAR. DIMENSIONAL ANALYSIS OF THE FEMORAL AND TIBIAL COMPONENTS DETERMINED THAT THE PRODUCT, WHERE MEASURED, WAS CONFORMING TO PRINT SPECIFICATIONS. ACCURATE DIMENSIONAL ANALYSIS COULD NOT BE COMPLETED ON THE ARTICULAR SURFACE DUE TO THE WEAR. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 60660483

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R NEXGEN MIS STEMMED TIBIAL COMPONENT:| CATALOG #00595003701, LOT #60352909