BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL INSERT

    MDR report key: 9367550 · Received November 24, 2019

    Report

    Report Number
    1818910-2019-116888
    Event Type
    Injury
    Date Received
    November 24, 2019
    Date of Event
    September 1, 2006
    Report Date
    November 5, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON 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: CORRECTED: H6. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THE REPORTED EVENT WAS RETURNED TO THE INVESTIGATION SITE. 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. DEVICE HISTORY LOT : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE ARTICLE RECEIVED ENTITLED "THE IMPORTANCE OF A BALANCED-GAP TECHNIQUE IN ROTATING-PLATFORM KNEES." LITERATURE ARTICLE "THE IMPORTANCE OF A BALANCED-GAP TECHNIQUE IN ROTATING-PLATFORM KNEES" (2006) BY JOHN CHIAVETTA ET AL PUBLISHED BY ORTHOPEDICS WAS REVIEWED. THE ARTICLE PURPOSE: TO DETERMINE THE PREVALENCE OF SPIN-OUT IN A LARGE SERIES OF P.F.C. SIGMA AND TO COMPARE THE PREVALENCE OF SPIN-OUT IN THIS SERIES TO HISTORICAL CONTROLS REPORTED IN THE LITERATURE. THE ARTICLE REPORTS: FROM APRIL 2000 TO JUNE 2003, 540 PFC SIGMA DEVICES WERE IMPLANTED AT THE AUTHORS' INSTITUTION. OUT OF THESE, 426 KNEES IN 393 PATIENTS WERE INCLUDED IN THE STUDY. THERE WERE 0 CASES OF SPINOUT OR DISSOCIATION OF THE POLYETHYLENE FROM THE TIBIAL TRAY. THE PREVALENCE OF SPINOUT WITHIN THIS STUDY WAS SIGNIFICANTLY LESS THAN OTHER PREVIOUS STUDIES. THE AUTHORS CONCLUDED THIS WAS BECAUSE THE GAP-BALANCING TECHNIQUE WAS SUCCESSFUL IN SUPPRESSING THESE PARTICULAR ADVERSE EVENTS. CEMENT USAGE/MANUFACTURER WAS NOT MENTIONED WITHIN THE ARTICLE. PATELLA RESURFACING WAS ALSO NOT MENTIONED WITHIN THE ARTICLE. DEPUY PRODUCTS INVOLVED: PFC SIGMA MB. COMPLICATIONS: TIBIOFEMORAL DISLOCATION (1), INFECTION (1), PERIPROSTHETIC FRACTURE (1), SURGICAL INTERVENTION (2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162001 UNKNOWN KNEE TIBIAL INSERT KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention