BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL INSERT

    MDR report key: 9293861 · Received November 7, 2019

    Report

    Report Number
    1818910-2019-114944
    Event Type
    Injury
    Date Received
    November 7, 2019
    Date of Event
    April 10, 2009
    Report Date
    October 22, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    LITERATURE ARTICLE RECEIVED ENTITLED: "REVISION TOTAL KNEE ARTHROPLASTY USING THE PFC SIGMA KNEE SYSTEM" LITERATURE ARTICLE "REVISION TOTAL KNEE ARTHROPLASTY USING THE PFC SIGMA KNEE SYSTEM" (2009) BY SIN WOO LIM, MAN SIK YOU, AND DONG HEON KIM PUBLISHED BY THE JOURNAL OF KOREAN KNEE SOCIETY WAS REVIEWED. THE ARTICLE PURPOSE: TO ANALYZE THE CAUSES, CLINICAL AND RADIOLOGICAL RESULTS OF REVISION SURGERY WITH PFC SIGMA KNEE IMPLANTS. THE ARTICLE REPORTS: FROM MARCH 1999 TO MAY 2005, 34 PATIENTS WHO COULD BE FOLLOWED-UP FOR MORE THAN 4 YEARS WERE THE SUBJECTS OF THIS STUDY. PFC SIGMA KNEE SYSTEM WAS USED IN ALL CASES. PATELLA REVISION WAS ONLY DONE IN CASES WHERE PATELLA "DAMAGE AND FIXATION IS POOR". THE ACTUAL EXTENT OF PATELLA RESURFACING WAS NOT DISCLOSED. THE MEAN KNEE SCORE IMPROVED FROM 45.1 POINTS PREOPERATIVELY TO 84.5 POINTS POSTOPERATIVELY, AND THE MEAN FUNCTIONAL SCORE IMPROVED FROM 37.2 POINTS PREOPERATIVELY TO 78.2 POINTS POSTOPERATIVELY. THE RANGE OF MOTION WAS INCREASED FROM PREOPERATIVE 97°TO POSTOPERATIVE 109°. THE SUBJECTIVE SATISFACTION WAS 8.2 POINTS. THERE WERE TWO CASES OF SUPERFICIAL INFECTION WHICH WERE TREATED SUCCESSFULLY SHORTLY POST-OPERATION. THERE WAS 1 CASE OF WOUND DEHISCENCE THAT WAS SUCCESSFULLY TREATED WITHIN THREE WEEKS WITH WASHING AND SKIN GRAFTING. OTHERWISE, THE REVISION SURGERIES PERFORMED IN THIS STUDY WERE OVERALL VERY SUCCESSFUL. DEPUY PRODUCTS INVOLVED: PFC SIGMA. COMPLICATIONS: IMPAIRED HEALING (1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088353 UNKNOWN KNEE TIBIAL INSERT KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention