BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN KNEE TIBIAL TRAY

    MDR report key: 9212617 · Received October 20, 2019

    Report

    Report Number
    1818910-2019-110835
    Event Type
    Malfunction
    Date Received
    October 20, 2019
    Date of Event
    August 2, 2011
    Report Date
    October 10, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    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 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: 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. 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

    PRODUCT COMPLAINT # (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: "TH E POSITION OF PROXIMAL REFERENCE POINT OF TIBIA PLATEAU FOR CORRECT TIBIAL OSTEOTOMY IN TOTAL KNEE REPLACEMENT: PROSPECTIVE RANDOMIZED AND 6 YEARS FOLLOW-UP STUDY." LITERATURE ARTICLE "THE POSITION OF PROXIMAL REFERENCE POINT OF TIBIA PLATEAU FOR CORRECT TIBIAL OSTEOTOMY IN TOTAL KNEE REPLACEMENT: PROSPECTIVE RANDOMIZED AND 6 YEARS FOLLOW-UP STUDY" (2011) BY KYE YOUNG HAN, MD AND WOO YOUNG CHAE, MD PUBLISHED BY KNEE SURGERY & RELATED RESEARCH HTTP://DX.DOI.ORG/10.5792/KSRR.2011.23.4.197 WAS REVIEWED. THE ARTICLE PURPOSE: TO FIND OUT WHETHER THE LATERAL EMINENCE OF TIBIA COULD SERVE AS A REFERENCE POINT FOR PROXIMAL TIBIAL OSTEOTOMY DURING TOTAL KNEE ARTHROPLASTY AND RESULTS FROM 6-YEARS FOLLOW UP PERIOD WERE REPORTED. THE ARTICLE REPORTS: FORTY-SIX PATIENTS WHO RECEIVED TOTAL KNEE REPLACEMENT ARTHROPLASTY FROM APRIL TO DECEMBER 2004, WERE RANDOMLY DIVIDED INTO TWO GROUPS. THE AUTHORS REPORTED THAT THERE WAS A SIGNIFICANT DIFFERENCE IN THE PAIN SCORE BETWEEN GROUP I (82.9) AND II (91.4) (P=0.032), RESPECTIVELY. THEY CONCLUDED THAT BY MOVING THE REFERENCE POINT OF PROXIMAL TIBIAL OSTEOTOMY LATERALLY, LOWER INCIDENCE OF OUTLIER AND RESIDUAL VARUS DEFORMITY COULD BE ACHIEVED. THERE WAS ONLY ONE INCIDENCE OF AN ADVERSE EVENT THAT WAS LOOSENING AND SUBSIDENCE OF THE TIBIAL COMPONENT. THIS ADVERSE EVENT WAS REPORTED FROM AN INDIVIDUAL WITHIN GROUP 1 WHERE PFC SIGMA WAS USED IN 18 CASES AND A COMPETITOR PRODUCT IN 7 OF THE CASES. THE AUTHOR'S DO NOT DISCLOSE WHETHER THE SUBSIDENCE AND LOOSENING WAS IN A DEPUY PRODUCT OR NOT, BUT WE WILL ASSUME IT WAS BASED ON THE PRODUCTS NUMBERS WITHIN THE GROUP. PATELLA RESURFACING AND CEMENT USAGE/MANUFACTURER WERE NOT DISCUSSED. SURGICAL INTERVENTION TO ADDRESS THE LOOSENING AND SUBSIDENCE WAS NOT MENTIONED. DEPUY PRODUCTS INVOLVED: PFC SIGMA. COMPLICATIONS: TIBIAL TRAY LOOSENING (1) AND SUBSIDENCE (1) (IN THE SAME PRODUCT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006786 UNKNOWN KNEE TIBIAL TRAY KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1