BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    MDR report key: 4575153 · Received March 4, 2015

    Report

    Report Number
    1822565-2015-00267
    Event Type
    Injury
    Date Received
    March 4, 2015
    Date of Event
    April 30, 2013
    Report Date
    January 29, 2015
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    Z-2413-2010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING AMENDED TO REFLECT CHANGES. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING AMENDED TO REFLECT CHANGES. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE TIBIAL COMPONENT DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES. THIS DEVICE IS USED FOR TREATMENT. OPERATIVE NOTES FROM THE REVISION SURGERY INDICATE THAT THE TIBIAL COMPONENT WAS FOUND TO BE GROSSLY LOOSE. IT IS NOTED THAT THIS MIS TIBIAL COMPONENT WAS IMPLANTED WITHOUT A DROP DOWN STEM EXTENSION. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THE REVISION SURGERY MAY BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION IN (B)(4) 2010. A FIELD ACTION WAS CONDUCTED ON (B)(4) 2010, IN WHICH ZIMMER STRONGLY RECOMMENDS THE USE OF A DROP DOWN STEM EXTENSION IN CONJUNCTION WITH THE BASEPLATE AND CONFIRMING THE CORRECT TECHNIQUE FOR CEMENTING THE NEXGEN MIS TIBIAL COMPONENT WAS FOLLOWED.

    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
    151792 NEXGEN MIS STEMMED TIBIAL COMPONENT JWH JWH ZIMMER, INC. 60790430

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention LOT #UNK| NEXGEN MIS TIBIAL COMPONENT, CATALOG #UNK,