BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGC ANATOM INTRLK FEM PROS L 65

    MDR report key: 2882224 · Received December 20, 2012

    Report

    Report Number
    3002806535-2012-00375
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 26, 2012
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PK921182
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR REVISION WAS MAINLY TIBIAL MAL-ALIGNMENT. REVIEW OF THE MANUFACTURING HISTORY REPORTS AND INSPECTION SHEETS FOR THE RETURNED ITEMS SHOWED NO ABNORMALITY AND ONE DEVIATION THAT WAS NOT APPLICABLE TO THE INVESTIGATION.DIMENSIONAL EVALUATION WAS COMPLETED WITH THE RESULTS CONFIRMING THAT THE DIMENSIONS WERE CORRECT AND TO SPECIFICATION. ALL ITEMS WERE MARKED CORRECTLY PER SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY KNEE SURGERY ON (B)(6) 2012. REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2012 DUE TO TIBIAL MAL-ALIGNMENT. NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGC ANATOM INTRLK FEM PROS L 65 AGC V2 INTERLOK TIBIAL JWH BIOMET UK LTD. N/A 2560456

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R