BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL INSERT

    MDR report key: 9407925 · Received December 4, 2019

    Report

    Report Number
    1818910-2019-119917
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    November 8, 2009
    Report Date
    November 13, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. 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. (B)(4).

    Description of Event or Problem · 1

    LITERATURE ARTICLE RECEIVED ENTITLED: "FUNCTIONAL OUTCOME OF PFC SIGMA FIXED AND ROTATING-PLATFORM TOTAL KNEE ARTHROPLASTY. A PROSPECTIVE RANDOMISED CONTROLLED TRIAL" LITERATURE ARTICLE "FUNCTIONAL OUTCOME OF PFC SIGMA FIXED AND ROTATING-PLATFORM TOTAL KNEE ARTHROPLASTY. A PROSPECTIVE RANDOMISED CONTROLLED TRIAL" (2010) BY BIRGIT HANUSCH & THAI NURN LOU & GARY WARRINER & ANTHONY HUI & PAUL GREGG PUBLISHED BY INTERNATIONAL ORTHOPAEDICS DOI 10.1007/S00264-009-0901-3 WAS REVIEWED. THE ARTICLE PURPOSE: TO DETERMINE WHETHER THERE IS A DIFFERENCE IN FUNCTIONAL OUTCOME BETWEEN THE PFC SIGMA FIXED-BEARING AND ROTATING-PLATFORM TOTAL KNEE REPLACEMENT SYSTEMS. THE ARTICLE REPORTS: ONE HUNDRED TWENTY PATIENTS WERE RANDOMISED TO RECEIVE EITHER A FIXED-BEARING OR ROTATING-PLATFORM PFC SIGMA TOTAL KNEE REPLACEMENT. AT A MEAN FOLLOW-UP OF 13.4 MONTHS THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE IN MEAN ROM, OKS AND KSS BETWEEN THE TWO GROUPS. THE PATELLA WAS NOT RESURFACED AND CEMENT WAS USED IN THE TIBIAL AND FEMORAL COMPONENTS, BUT THE MANUFACTURER WAS NOT DISCLOSED. DEPUY PRODUCTS INVOLVED: PFC SIGMA FB AND PFC SIGMA RP. COMPLICATIONS WITH PFC SIGMA FB: JOINT STIFFNESS (1), DEEP VEIN THROMBOSIS (1), PULMONARY EMBOLISM (1), SURGICAL INTERVENTION (1) COMPLICATIONS WITH PFC SIGMA RP: INFECTION (2), JOINT STIFFNESS (2), DEEP VEIN THROMBOSIS (3), PULMONARY EMBOLISM (3), SURGICAL INTERVENTION (4) THE FIRST THREE PRODUCTS ARE TO CAPTURE THE PFC SIGMA FB COMPONENTS. THE FOLLOWING THREE PRODUCTS ARE TO CAPTURE THE PFC SIGMA RP COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207494 UNKNOWN KNEE TIBIAL INSERT KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention