BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK NEXGEN CT-FLEX FEMORAL COMPONENT

    MDR report key: 3012301 · Received March 12, 2013

    Report

    Report Number
    1822565-2013-00465
    Event Type
    Injury
    Date Received
    March 12, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRIMARY SURGICAL REPORT PROVIDED INDICATED THAT THE MEDIAL AND LATERAL MENISCI AND ANTERIOR CRUCIATE LIGAMENT WERE REMOVED; IT DID NOT REVEAL INDICATIONS THAT THE RECOMMENDED SURGICAL TECHNIQUE WAS NOT FOLLOWED. NO X-RAYS WERE RECEIVED, SO CORRECT FIT AND ORIENTATION COULD NOT BE CHECKED. 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 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING CONSTANT PAIN AND CANNOT WALK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104539 UNK NEXGEN CT-FLEX FEMORAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other