BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LCCK FEMORAL COMPONENT

    MDR report key: 3111172 · Received May 8, 2013

    Report

    Report Number
    1822565-2013-00764
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    July 10, 2012
    Report Date
    April 11, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PRIMARY SURGICAL REPORT DID NOT REVEAL ANY DEVIATIONS FROM THE SURGICAL TECHNIQUE. THE SURGICAL REPORT FOR THE REVISION STATES THAT THE FEMORAL COMPONENT WAS REVISED DUE TO ASEPTIC LOOSENING. NO X-RAYS WERE RECEIVED, SO NO CHECK COULD BE MADE FOR CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. 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 UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION CODES: 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 INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202224 NEXGEN LCCK FEMORAL COMPONENT JWH ZIMMER, INC. 61617564

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention NEXGEN STEM EXTENSION: CATALOG #00598801614,| LOT #61508180| LOT #61509931, MANUFACTURED AT ZIMMER BV,| LOT #61479967| CATALOG #00599003501, LOT #00599003501,| NEXGEN POSTERIOR FEMORAL AUGMENT BLOCK:| PONCE, PUERTO RICO.| CATALOG #00599003510, LOT #61626119,| NEXGEN DISTAL FEMORAL AUGMENT BLOCK: