BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL INSERT

    MDR report key: 13591022 · Received February 24, 2022

    Report

    Report Number
    1818910-2022-03445
    Event Type
    Injury
    Date Received
    February 24, 2022
    Date of Event
    January 1, 2022
    Report Date
    February 24, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED. AVAILABLE XRAY EVIDENCE INCLUDED IN THE STUDY WAS REVIEWED. NO FAILURE OF ANY DEPUY PRODUCT CAN BE OBSERVED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED FOR THIS DEVICE.

    Description of Event or Problem · 0

    LITERATURE ARTICLE ENTITLED ¿NOTCHING IS LESS, IF FEMORAL COMPONENT SAGITTAL POSITIONING IS PLANNED PERPENDICULAR TO DISTAL FEMUR ANTERIOR CORTEX AXIS, IN NAVIGATED TKA.¿ KANNA R, RAVICHANDRAN C, SHETTY GM. KNEE SURG RELAT RES. 2021 DEC 24;33(1):46. DOI: 10.1186/S43019-021-00129-9. PMID: 34952652; PMCID: PMC8709981. THE ARTICLE'S PURPOSE WAS TO DETERMINE IF, BY OPTING TO PLACE THE FEMORAL COMPONENT PERPENDICULAR TO DISTAL FEMUR ANTERIOR CORTEX AXIS (DCX), NOTCHING CAN BE REDUCED IN NAVIGATED TKA. PATIENT DATA: 171 PATIENTS WERE AVAILABLE FOR ANALYSIS WITH BILATERAL KNEES. MEAN AGE OF PATIENTS AT THE TIME OF SURGERY WAS 66.5±8.5 YEARS (RANGE 44¿89 YEARS). THERE WERE 60 (35.1%) MALE AND 111 (64.9%) FEMALE PATIENTS. MEAN BODY MASS INDEX WAS 29±4 KG/M2. IT IS NOTED THAT CONSTRUCTS IN THE STUDY WERE CEMENTED (UNKNOWN CEMENT MANUFACTURER) AND HAD PATELLA IMPLANTS. DEPUY PRODUCTS: P.F.C. SIGMA CONSTRUCT AND ATTUNE CONSTRUCT. THE ADVERSE EVENTS PROVIDED DID NOT SPECIFY WHAT TYPE OF CONSTRUCT WAS INVOLVED WITH THE BONE FRACTURE OR INFECTION. PAIN AND NOTCHING OCCURRED IN BOTH THE ATTUNE AND SIGMA KNEES. ADVERSE EVENTS (PATIENT SPECIFIC EVENTS WERE NOT SPECIFIED). FEMORAL BONE NOTCHING (46 TOTAL OCCURRENCES) - TREATMENT NOT SPECIFIED. PAIN (19 TOTAL OCCURRENCES) - TREATMENT NOT SPECIFIED . POST OP SUPRA-CONDYLAR BONE FRACTURE (1 OCCURRENCE) - OPEN REDUCTION AND INTERNAL FIXATION. POST OP INFECTION (1 OCCURRENCE) ¿ IRRIGATION AND DEBRIDEMENT PLUS POLY INSERT EXCHANGE.

    Description of Event or Problem · 0

    LITERATURE ARTICLE ENTITLED ¿NOTCHING IS LESS, IF FEMORAL COMPONENT SAGITTAL POSITIONING IS PLANNED PERPENDICULAR TO DISTAL FEMUR ANTERIOR CORTEX AXIS, IN NAVIGATED TKA.¿ KANNA R, RAVICHANDRAN C, SHETTY GM. KNEE SURG RELAT RES. 2021 DEC 24;33(1):46. DOI: 10.1186/S43019-021-00129-9. PMID: 34952652; PMCID: PMC8709981. THE ARTICLE'S PURPOSE WAS TO DETERMINE IF, BY OPTING TO PLACE THE FEMORAL COMPONENT PERPENDICULAR TO DISTAL FEMUR ANTERIOR CORTEX AXIS (DCX), NOTCHING CAN BE REDUCED IN NAVIGATED TKA. PATIENT DATA: 171 PATIENTS WERE AVAILABLE FOR ANALYSIS WITH BILATERAL KNEES. MEAN AGE OF PATIENTS AT THE TIME OF SURGERY WAS 66.5±8.5 YEARS (RANGE 44¿89 YEARS). THERE WERE 60 (35.1%) MALE AND 111 (64.9%) FEMALE PATIENTS. MEAN BODY MASS INDEX WAS 29±4 KG/M2. IT IS NOTED THAT CONSTRUCTS IN THE STUDY WERE CEMENTED (UNKNOWN CEMENT MANUFACTURER) AND HAD PATELLA IMPLANTS. DEPUY PRODUCTS: P.F.C. SIGMA CONSTRUCT AND ATTUNE CONSTRUCT. THE ADVERSE EVENTS PROVIDED DID NOT SPECIFY WHAT TYPE OF CONSTRUCT WAS INVOLVED WITH THE BONE FRACTURE OR INFECTION. PAIN AND NOTCHING OCCURRED IN BOTH THE ATTUNE AND SIGMA KNEES. ADVERSE EVENTS (PATIENT SPECIFIC EVENTS WERE NOT SPECIFIED). FEMORAL BONE NOTCHING (46 TOTAL OCCURRENCES) - TREATMENT NOT SPECIFIED. PAIN (19 TOTAL OCCURRENCES) - TREATMENT NOT SPECIFIED . POST OP SUPRA-CONDYLAR BONE FRACTURE (1 OCCURRENCE) - OPEN REDUCTION AND INTERNAL FIXATION. POST OP INFECTION (1 OCCURRENCE) ¿ IRRIGATION AND DEBRIDEMENT PLUS POLY INSERT EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107150 UNKNOWN KNEE TIBIAL INSERT KNEE TIBIAL INSERT NJL DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention