BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 2994413 · Received March 5, 2013

    Report

    Report Number
    2648920-2013-00061
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    December 5, 2012
    Report Date
    February 11, 2013
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: REVIEW OF PRIMARY SURGICAL REPORT PROVIDED DID NOT REVEAL INDICATIONS THAT THE RECOMMENDED SURGICAL TECHNIQUE WAS NOT FOLLOWED. REVISION SURGICAL REPORT INDICATED THE TIBIAL COMPONENT WAS GROSSLY LOOSE AND SUBSIDED INTO SIGNIFICANT VARUS. NO X-RAYS WERE RECEIVED, SO NO CHECK COULD BE MADE FOR CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. 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

    A PRODUCT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS FOR THE PART AND LOT COMBINATIONS OF THE RELATED COMPONENTS. OPERATIVE NOTES FROM THE REVISION SURGERY INDICATE THAT THE ARTICULAR SURFACE WAS NOTED TO BE WORN AND LOOSE. THE ANTERIOR HALF OF THE DISTAL LATERAL FEMORAL CONDYLE WAS NOTED TO BE AN OSTEOLYTIC CAVITY. THE PROXIMAL TIBIA WAS NOTED TO HAVE A LARGE AREA OF OSTEOLYSIS MEDIALLY AND SOME LATERAL BONE LOSS. PER THE NEXGEN CR-FLEX AND LPS-FLEX PACKAGE INSERT, LOOSENING OR FRACTURE/DAMAGE OF THE PROSTHETIC KNEE COMPONENTS OR SURROUNDING TISSUES IS A KNOWN RISK OF THIS PROCEDURE. THE PACKAGE INSERT ALSO INDICATES THAT WEAR DEBRIS CAN INITIATE OSTEOLYSIS WHICH MAY RESULT IN LOOSENING OF THE IMPLANT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS DEVICE IS USED FOR TREATMENT. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE BONE CEMENT AND FEMORAL COMPONENT IDENTIFIED NO DEVIATIONS OR ANOMALIES.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94074 NEXGEN STEMMED TIBIAL COMPONENT JWH ZIMMER 22772400

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention