BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE FEMORAL ADAPTOR

    MDR report key: 11107038 · Received January 4, 2021

    Report

    Report Number
    1818910-2021-28109
    Event Type
    Injury
    Date Received
    January 4, 2021
    Report Date
    December 21, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.

    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.

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE TITLED, "MODERN FULL-COMPONENT ASEPTIC REVISION TOTAL KNEE ARTHROPLASTIES HAVE SIMILAR RECOVERIES COMPARED WITH PRIMARY TOTAL KNEE ARTHROPLASTY PATIENTS WHEN APPLYING AN ENHANCED RECOVERY ANAESTHETIC AND ANALGESIC PROTOCOL" WRITTEN BY T. COSTALES, D.M. CHAPMAN, M.J. MILLER, AND D.F. DALURY PUBLISHED BY THE BONE AND JOINT JOURNAL 2020 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO DETERMINE EARLY-TERM CLINICAL FUNCTIONAL OUTCOMES BETWEEN A MATCHED GROUP OF ASEPTIC FULL-COMPONENT REVISION AND PRIMARY TKA PATIENTS TREATED WITH THE IDENTICAL PAIN AND REHABILITATION PROTOCOLS DURING THE SAME TIME PERIOD. DATA WAS COMPILED FROM 40 REVISION PATIENTS (ORIGINAL IMPLANTS NOT IDENTIFIED) AND 40 PRIMARIES. BOTH REVISION GROUP AND PRIMARY GROUP UTILIZED DEPUY PRODUCTS. CEMENT MANUFACTURER IS NOT IDENTIFIED. ARTICLE REPORTS PATELLA WAS NOT REVISED IN THE REVISION GROUP AND MAKES NO MENTION OF PATELLAR RESURFACING FOR THE PRIMARY GROUP. RESULTS WERE NO SIGNIFICANT FINDINGS FOR ADVERSE EVENTS. EACH GROUP HAD ONE HOSPITAL READMISSION FOR GASTROINTESTINAL DISORDER IN THE REVISION GROUP AND POSTOPERATIVE URINARY RETENTION IN THE PRIMARY GROUP. REVISION GROUP DEPUY PRODUCTS: SIGMA FEMORAL STEM, SIGMA FEMORAL SLEEVE, SIGMA ADAPTOR, SIGMA ADAPTOR BOLT, SIGMA FEMORAL COMPONENT, POLY INSERT, SIGMA TIBIAL TRAY, SIGMA TIBIAL SLEEVE, SIGMA TIBIAL STEM ADVERSE EVENT FOR REVISION GROUP: HOSPITAL RE-ADMISSION FOR GASTROINTESTINAL DISORDER (NO FURTHER INFORMATION PROVIDED). PRIMARY GROUP DEPUY PRODUCTS: SIGMA PFC FEMORAL, SIGMA PFC POLY INSERT, SIGMA PFC TRAY. ADVERSE EVENT FOR PRIMARY GROUP: HOSPITAL RE-ADMISSION FOR URINARY RETENTION (NO FURTHER INFORMATION PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4640 UNKNOWN KNEE FEMORAL ADAPTOR KNEE FEMORAL ADAPTOR JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention