BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL TRAY

    MDR report key: 9210096 · Received October 18, 2019

    Report

    Report Number
    1818910-2019-108882
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    January 2, 2013
    Report Date
    September 27, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. PRODUCT COMPLAINT # (B)(4). 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

    (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 "NO DIFFERENCE IN ACCURACY BETWEEN PINLESS AND CONVENTIONAL COMPUTER-ASSISTED SURGERY IN TOTAL KNEE ARTHROPLASTY". LITERATURE ARTICLE "NO DIFFERENCE IN ACCURACY BETWEEN PINLESS AND CONVENTIONAL COMPUTER-ASSISTED SURGERY IN TOTAL KNEE ARTHROPLASTY" (2013) BY C. BAIER, G. MADERBACHER, H. R. SPRINGORUM, F. ZEMAN, W. FITZ, J. SCHAUMBURGER, J. GRIFKA, AND J. BECKMANN PUBLISHED BY KNEE SURGERY SPORTS TRAUMATOLOGICAL ARTHROSCOPY DOI: 10.1007/S00167-013-2430-2 WAS REVIEWED FOR MDR REPORTABILITY. THE ARTICLE PURPOSE: TO EVALUATE THE ACCURACY OF A SO-CALLED PINLESS CTFREE VERSION OF KNEE NAVIGATION (PINLESS CAS) ABANDONING THE REFERENCE PINS AND REDUCING THE NECESSARY WORKFLOW TO A MINIMUM. THE ARTICLE REPORTS: THIRTY-TWO CONSECUTIVE PATIENTS RECEIVED A STANDARD TOTAL KNEE ARTHROPLASTY (DEPUY, PFC, JOHNSON AND JOHNSON) ASSISTED BY CT-FREE CAS (BRAINLAB, FELDKIRCHEN, GERMANY). THE OPERATIONS WERE PERFORMED BY TWO EXPERIENCED SURGEONS ([500 TKA) VIA A STANDARD MEDIAL PARAPATELLAR APPROACH WITH TOURNIQUET, FULLY CEMENTED IN SPINAL ANAESTHESIA. THE PATIENT POPULATION CONSISTED OF 30 PATIENTS, 21 WOMEN AND 9 MEN WITH A MEAN AGE OF 67 YEARS. THE USE OF CAS DURING TKA HAS PROVEN SIGNIFICANT REDUCTION IN OUTLIERS CONCERNING ALIGNMENT OF THE LIMB AND COMPONENT POSITION. OPPONENTS OF CAS OFTEN CLAIM THE LENGTHENING OF THE SURGICAL TIME AND THE ADDITIONAL TRAUMA AND RISKS DUE TO THE REQUIRED PINS. IN CLINICAL ROUTINE, PINLESS CAS COULD COMPRISE THE ADVANTAGES OF CAS WHILE LEAVING THE DISADVANTAGES ASIDE. IT REDUCES SURGICAL TIME AND AVOIDS PROCEDURE-ASSOCIATED COMPLICATIONS ASSOCIATED WITH THE TRACKING PINS OF CONVENTIONAL NAVIGATION SYSTEMS. IN THE IMMEDIATE POSTOPERATIVE PERIOD, ONE WOUND DEHISCENCE REQUIRED DEBRIDEMENT AND SECONDARY SUTURE ON DAY 9 AFTER THE TKA. NO OTHER REVISION WAS NECESSARY, AND OTHER COMPLICATIONS SUCH AS INFECTION, FRACTURES, DVT OR ELSE DID NOT OCCUR. CEMENT USAGE AND PATELLA RESURFACING WAS NOT MENTIONED IN THIS ARTICLE. DEPUY PRODUCTS INVOLVED: UNKNOWN DEPUY KNEE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005504 UNKNOWN KNEE TIBIAL TRAY KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention