BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA C/S NPOR FEM RT SZ 4

    MDR report key: 3267851 · Received August 7, 2013

    Report

    Report Number
    1818910-2013-23187
    Event Type
    Injury
    Date Received
    August 7, 2013
    Date of Event
    August 8, 2008
    Report Date
    December 20, 2013
    Manufacturer
    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT R
    Product Code
    JWH
    PMA / PMN Number
    PK950010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED AND IS PRESUMED YET IMPLANTED, AS NO REVISION SURGERY HAS BEEN REPORTED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED AND ARE PRESUMED YET IMPLANTED. REVIEW OF THE SUPPLIED PATIENT MEDICAL RECORDS CONFIRMED PATIENT LESION/SCAR TISSUE THAT COULD CONTRIBUTE TO THE REPORTED PATELLAR GRINDING. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR TO THE PATELLAR GRINDING AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THE PATIENT HAD PATELLAR GRIND SYNDROME. THE PATIENT UNDERWENT AN ARTHROSCOPY FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370395 PFC*SIGMA C/S NPOR FEM RT SZ 4 FEMORAL JWH THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT R 147054AB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention