BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE FEMORAL

    MDR report key: 9559455 · Received January 7, 2020

    Report

    Report Number
    1818910-2020-00927
    Event Type
    Injury
    Date Received
    January 7, 2020
    Date of Event
    January 1, 2017
    Report Date
    December 13, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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 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 "KNEELING AND STANDING UP FROM A CHAIR AS PERFORMANCE-BASED TESTS TO EVALUATE KNEE FUNCTION IN THE HIGH-FLEXION RANGE: A RANDOMIZED CONTROLLED TRIAL COMPARING A CONVENTIONAL AND A HIGH FLEXION TKA DESIGN" BY PAUL J. P. VAN DER VEN, SEBASTIAAN VAN DE GROES, JORRIT ZELLE, SANDER KOETER, GERJON HANNINK AND NICO VERDONSCHOT PUBLISHED BY MUSCULOSKELETAL DISORDERS (2017) DOI 10.1186/S12891-017-1657-3 WAS REVIEWED. THE ARTICLE'S PURPOSE: TO COMPARE A CONVENTIONAL TKA IMPLANT AND A HIGH FLEXION IMPLANT IN THEIR ABILITIES TO KNEEL AND STAND FROM A CHAIR IN ORDER TO ASSESS OVERALL KNEE FUNCTION. THE ARTICLE REPORTS: 56 PATIENTS WERE RANDOMIZED TO RECEIVE EITHER THE PFC SIGMA FB OR THE PFC SIGMA RP-F HIGH FLEXION IMPLANT. SIT-TO-STAND ANALYSES SHOWED NO DIFFERENCES IN ASYMMETRY BETWEEN THE HEALTHY AND AFFECTED LEG BETWEEN CONVENTIONAL AND HIGH-FLEXION TKA GROUP, WHILE THE PATIENTS IN THE CONVENTIONAL TKA GROUP HAD A SIGNIFICANTLY HIGHER ANGULAR VELOCITY AS COMPARED TO THE HIGH-FLEXION TKA GROUP. CEMENT MANUFACTURER WAS NOT IDENTIFIED. PATELLA RESURFACING WAS NOT MENTIONED WITHIN THE ARTICLE. THE ARTICLE REPORTS ADVERSE EVENTS ONLY ASSOCIATED IN THE CONVENTIONAL PFC SIGMA FB GROUP. DEPUY PRODUCTS: PFC SIGMA FB ADVERSE EVENTS: MEDICAL DEVICE SITE JOINT MOVEMENT IMPAIRMENT TREATED BY MANIPULATION UNDER ANETHESISA (1 PATIENT) DVT TREATED BY ANTI-COAGULANTS (1 PATIENT) PATELLA CLUNK TREATED BY ARTHROSCOPIC DEBRIDEMENT (1 PATIENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20267 UNKNOWN KNEE FEMORAL KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention