BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK KNEE FEMORAL SIGMA

    MDR report key: 12345887 · Received August 19, 2021

    Report

    Report Number
    1818910-2021-18232
    Event Type
    Injury
    Date Received
    August 19, 2021
    Date of Event
    May 4, 2020
    Report Date
    August 2, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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. DEVICE HISTORY LOT : A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    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

    "LITERATURE ARTICLE ENTITLED, ¿A RANDOMIZED CONTROLLED TRIAL COMPARING THE EFFICACIES OF KETOROLAC AND PARECOXIB FOR EARLY PAIN MANAGEMENT AFTER TOTAL KNEE ARTHROPLASTY,¿ BY ARTIT LAORUENGTHANA, ET. AL., PUBLISHED BY THE KNEE (2020), VOL. 27, PP. 1708-1714, WAS REVIEWED. THE PURPOSE OF THIS ARTICLE WAS TO COMPARE ANALGESIC EFFECT AND PERIOPERATIVE BLOOD LOSS (PBL) AFTER TOTAL KNEE ARTHROPLASTY (TKA) BETWEEN KETOROLAC (CONVENTIONAL NSAIDS) AND PARECOXIB (SELECTIVE COX-2 INHIBITOR) ADMINISTRATION IN 100 PATIENTS IMPLANTED WITH PRIMARY UNILATERAL TKA BETWEEN MAY 2017 AND FEBRUARY 2018. THERE WERE 50 PATIENTS IN THE KETOROLAC COHORT AND 50 IN THE PARECOXIB COHORT. ALL PATIENT RECEIVED AFFIXED BEARING, POSTERIOR STABILIZED PFC SIGMA TKA CEMENTED WITH UNKNOWN CEMENT. IT IS UNKNOWN IF THE PATELLAS WERE RESURFACED. THE AUTHORS CONCLUDED THAT PARECOXIB PROVIDES COMPARABLE ANALGESIC EFFECTS TO THOSE OF KETOROLAC. ADDITIONALLY, PERIOPERATIVE USE OF PARECOXIB IS SAFE AND IS ASSOCIATED WITH SIGNIFICANTLY LESS BLOOD LOSS AFTER TKA. ADVERSE EVENTS: 1 CASE OF DEEP VEIN THROMBOSIS TREATED WITH ANTICOAGULANTS. 1 PATIENT RECEIVED A TWO-STAGE REVISION TO TREAT PAIN AND PERIPROSTHETIC JOINT INFECTION. 1 PATIENT WITH PATELLAR CLUNK. THE AUTHORS DID NOT SPECIFY THE TYPE OF CONSERVATIVE TREATMENT PROVIDED. . IT IS UNKNOWN IF THE PATELLA WAS RESURFACED. CAPTURED IN THIS COMPLAINT: 3 PFC SIGMA FEMORAL COMPONENTS, TIBIAL TRAYS, AND TIBIAL INSERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241419 UNK KNEE FEMORAL SIGMA FEMORAL  NJL DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention