BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL TRAY

    MDR report key: 9330094 · Received November 15, 2019

    Report

    Report Number
    1818910-2019-116525
    Event Type
    Injury
    Date Received
    November 15, 2019
    Date of Event
    August 3, 2012
    Report Date
    October 30, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    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, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITERATURE ARTICLE RECEIVED TITLED, " COMPARISON OF CLINICAL OUTCOMES BETWEEN PATELLAR RESURFACING AND NONRESURFACING IN TOTAL KNEE ARTHROPLASTY: RETROSPECTIVE STUDY OF 130 CASES" LITERATURE ARTICLE "COMPARISON OF CLINICAL OUTCOMES BETWEEN PATELLAR RESURFACING AND NONRESURFACING IN TOTAL KNEE ARTHROPLASTY: RETROSPECTIVE STUDY OF 130 CASES" (2012) BY B LI, L BAI, Y FU, G WANG, M HE AND J WANG PUBLISHED BY THE JOURNAL OF INTERNATIONAL MEDICAL RESEARCH WAS REVIEWED. THE ARTICLE PURPOSE: TO COMPARE CLINICAL OUTCOMES BETWEEN PATELLAR RESURFACING AND NONRESURFACING IN TOTAL KNEE ARTHROPLASTY. THE ARTICLE REPORTS: DATA FROM PATIENTS WITH OSTEOARTHRITIS WHO UNDERWENT PRIMARY UNILATERAL TKA BETWEEN JANUARY 2000 AND DECEMBER 2002 AT ONE HOSPITAL, WERE REVIEWED RETROSPECTIVELY. ALL PATIENTS RECEIVED A PFC PS PROSTHESIS. DATA FROM 130 PATIENTS WERE REVIEWED. THERE WERE NO STATISTICAL DIFFERENCES BETWEEN EITHER GROUP IN TERMS OF LONG TERM CLINICAL OR FUNCTIONAL OUTCOMES BY ALL RECORDED METRICS. CEMENT WAS USED ALTHOUGHT MANUFACTURER WAS NOT DISCLOSED. NO WEAR OR LOOSENING WAS NOTED. ALL COMPLICATIONS WERE RESOLVED ASIDE FROM 4 FROM THE NON-RESURFACING GROUP WHO STILL SUFFERED FROM AKP UPON FINAL FOLLOW-UP. THE STIFFNESS WAS THE ONLY NONRESURFACING EXCLUSIVE COMPLICATION THEREFORE IT WILL ONLY BE CODED FOR THE FIRST THREE COMPONENTS. DEPUY PRODUCTS INVOLVED: PFC PS PROSTHESIS. COMPLICATIONS: INFECTION (1), SURGICAL INTERVENTION (9), STIFFNESS (1), PAIN (8), PATELLA FRACTURE (1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121933 UNKNOWN KNEE TIBIAL TRAY KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention