BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN KNEE PATELLA

    MDR report key: 15389676 · Received September 9, 2022

    Report

    Report Number
    1818910-2022-17488
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    March 2, 2022
    Report Date
    September 9, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    MIRF-000211763 ARTICLE ENTITLED THE DESIGN OF THE PATELLAR COMPONENT DOES NOT AFFECT THE PATIENT-REPORTED OUTCOME MEASURES IN PRIMARY POSTERIOR-STABILIZED TOTAL KNEE ARTHROPLASTY: A RANDOMIZED PROSPECTIVE STUDY WRITTEN BYOOG-JIN SHON AND GI BEOM KIM, PUBLISHED BY JOURNAL OF CLINICAL MEDICINE ON 02 MARCH 2022 WAS REVIEWED. THE ARTICLES PURPOSE WAS TO INVESTIGATE THE OUTCOMES OF PATELLAR RESURFACING WITH A MEDIALIZED DOME OR AN ANATOMICAL TYPE IN PATIENTS RECEIVING PRIMARY UNILATERAL POSTERIOR-STABILIZED TKA. BETWEEN MARCH 2019 AND JANUARY 2021, 98 KNEES WERE RANDOMLY ASSIGNED TO RECEIVE PATELLAR RESURFACING BY A MEDIALIZED DOME TYPE (GROUP D, 49 KNEES) OR AN ANATOMIC TYPE (GROUP A, 49 KNEES) THE PRIMARY OUTCOME WAS THE KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE. THE SECONDARY OUTCOMES WERE THE WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX, FELLER¿S PATELLA SCORE, THE KUJALA ANTERIOR KNEE PAIN SCORE, KNEE JOINT RANGE OF MOTION (ROM), AND POSTOPERATIVE COMPLICATIONS, INCLUDING PERIPROSTHETIC PATELLAR FRACTURE, PATELLAR TILT ANGLE, AND LATERAL PATELLAR SHIFT. PATIENT-REPORTED OUTCOMES WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN THE TWO GROUPS. ALL OPERATIONS WERE PERFORMED BY THE SAME SURGEON AND USED ATTUNE TKA SYSTEM. ALL PROSTHESES WERE USED WITH CEMENT AND FIXED -BEARING ANTIOXIDANT POLYETHYLENE INSERTS WERE USED IN ALL CASES. ROM, POSTOPERATIVE COMPLICATIONS: 0 PERIPROSTHETIC PATELLAR FRACTURE, PATELLAR TILT ANGLE, AND LATERAL PATELLAR SHIFT. PAIN AND STIFFNESS WERE REPORTED AT 3, 6, 12, MONTHS. ROM ISSUES, FLEXION CONTRACTURE WERE NOTED AS WELL AS PATELLA MAL-POSITIONING (SUCH AS ROTATIONAL ERROR) NO MEDICAL OR SURGICAL INTERVENTION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2122630 UNKNOWN KNEE PATELLA KNEE PATELLA JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown