BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK KNEE TIBIAL INSERT SIGMA

    MDR report key: 14929534 · Received July 6, 2022

    Report

    Report Number
    1818910-2022-12352
    Event Type
    Injury
    Date Received
    July 6, 2022
    Date of Event
    April 27, 2020
    Report Date
    July 6, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4). 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.

    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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: WANG Q, TAN G, MOHAMMED A, ZHANG Y, LI D, CHEN L, KANG P. ADDING CORTICOSTEROIDS TO PERIARTICULAR INFILTRATION ANALGESIA IMPROVES THE SHORT-TERM ANALGESIC EFFECTS AFTER TOTAL KNEE ARTHROPLASTY: A PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED CONTROLLED TRIAL. KNEE SURG SPORTS TRAUMATOL ARTHROSC. 2021 MAR;29(3):867-875. DOI: 10.1007/S00167-020-06039-9. EPUB 2020 MAY 2. PMID: 32361928. OBJECTIVE AND METHODS: PATIENTS RECEIVING DEPUY SIGMA FIXED-BEARING OR ROTATING-PLATFORM, POSTERIOR STABILIZED TOTAL KNEE PROSTHESES, WERE RANDOMIZED TO THE CORTICOSTEROID OR CONTROL GROUP (DOUBLE-BLINDED). THE PATIENTS IN THE CORTICOSTEROID GROUP RECEIVED A PERIARTICULAR INFILTRATION OF AN ANALGESIC COCKTAIL OF ROPIVACAINE, EPINEPHRINE, AND DEXAMETHASONE. DEXAMETHASONE WAS OMITTED FROM THE COCKTAIL IN THE CONTROL GROUP. THE PRIMARY OUTCOMES WERE POSTOPERATIVE PAIN [ASSESSED USING A VISUAL ANALOG SCALE (VAS)], TIME UNTIL THE ADMINISTRATION OF FIRST RESCUE ANALGESIA OF MORPHINE SULFATE, OVERALL MORPHINE CONSUMPTION, AND POSTOPERATIVE INFLAMMATORY BIOMARKERS [C-REACTIVE PROTEIN (CRP) AND INTERLEUKIN-6 (IL-6)]. THE SECONDARY OUTCOMES WERE FUNCTIONAL RECOVERY, ASSESSED BY THE RANGE OF KNEE MOTION, QUADRICEPS STRENGTH, AND DAILY AMBULATION DISTANCE. THE TERTIARY OUTCOMES INCLUDED POSTOPERATIVE ADVERSE EFFECTS. RESULTS: ADDING CORTICOSTEROIDS TO AN ANALGESIC COCKTAIL FOR PIA CAN MILDLY IMPROVE EARLY PAIN RELIEF AND ACCELERATE RECOVERY IN THE FIRST 24 H AFTER TOTAL KNEE ARTHROPLASTY. TERTIARY ADVERSE EVENTS (COMPLICATIONS): 32: POST-OP NAUSEA. 18: POST-OP VOMITING. 28: POST-OP WOUND SWELLING. 4: DELAYED WOUND HEALING. 3: DEEP VENOUS THROMBOSIS. 9 : CHRONIC PAIN. 2: NERVE DAMAGE (FOOT-DROP - RESOLVED WITHIN 24 HOURS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431368 UNK KNEE TIBIAL INSERT SIGMA KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention