BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE CONSTRUCT SIGMA

    MDR report key: 20095976 · Received August 29, 2024

    Report

    Report Number
    1818910-2024-18326
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    May 22, 2024
    Report Date
    August 29, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    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). THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: NATESAN R, ISTIYAK M, DHANASEKARA RAJA P, RAJASEKARAN S. OPTIMIZING TOURNIQUET PRESSURE IN PRIMARY TOTAL KNEE ARTHROPLASTY: LIMB OCCLUSION PRESSURE VS SYSTOLIC BLOOD PRESSURE METHOD: A RANDOMISED CONTROLLED STUDY. INDIAN J ORTHOP. 2024 MAY 22;58(7):971-978. DOI: 10.1007/S43465-024-01177-5. PMID: 38948377; PMCID: PMC11208337. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. H6 COMPONENT CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (G07002) USED TO CAPTURE NO FINDINGS AVAILABLE. 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. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: NATESAN R, ISTIYAK M, DHANASEKARA RAJA P, RAJASEKARAN S. OPTIMIZING TOURNIQUET PRESSURE IN PRIMARY TOTAL KNEE ARTHROPLASTY: LIMB OCCLUSION PRESSURE VS SYSTOLIC BLOOD PRESSURE METHOD: A RANDOMISED CONTROLLED STUDY. INDIAN J ORTHOP. 2024 MAY 22;58(7):971-978. DOI: 10.1007/S43465-024-01177-5. PMID: 38948377; PMCID: PMC11208337. OBJECTIVE/METHODS/STUDY DATA: THE PRIMARY AIM OF THIS PROSPECTIVE RANDOMIZED CONTROLLED TRIAL WAS TO DETERMINE WHETHER THE LIMB OCCLUSION PRESSURE (LOP) METHOD FOR DETERMINING OPTIMAL TOURNIQUET PRESSURE REDUCES THE CUFF PRESSURE DURING TKA AND IF THIS RESULTS IN LESS POST-OPERATIVE THIGH PAIN WHEN COMPARED TO THE SBP METHOD. THE SECONDARY AIM WAS TO DETERMINE WHETHER THESE TWO TECHNIQUES OF CALCULATING TOURNIQUET PRESSURE DIFFERED IN TERMS OF KNEE RANGE OF MOTION, THE QUALITY OF THE BLOODLESS FIELD, BLOOD LOSS AND WOUND COMPLICATIONS. FROM (B)(6) 2022, A TOTAL OF 311 PATIENTS WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE RANDOMIZED IN TWO GROUPS: GROUP A (LIMB OCCLUSION PRESSURE [LOP]) HAD 154 PATIENTS (22 MALE AND 132 FEMALE) AND GROUP B (SYSTOLIC BLOOD PRESSURE [SBP]) HAD 157 PATIENTS (35 MALE AND 122 FEMALE). BOTH GROUPS¿ AVERAGE AGES WERE 62.3+- 5.04 YEARS AND 63.4+- 8.02 YEARS, RESPECTIVELY. THE SAME SURGICAL TECHNIQUE AND IMPLANT (PFC SIGMA, DEPUY) WERE USED THROUGHOUT ALL SURGERIES PERFORMED BY A SINGLE SKILLED SURGEON. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES PFC SIGMA. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT SIGMA (QTY (B)(4): -IN GROUP B, 51.6% HAD MODERATE TO SEVERE THIGH PAIN, WHILE 53.3% HAD MILD TO MODERATE THIGH PAIN. THE SAME POSTOPERATIVE PAIN RELIEF TREATMENT WAS GIVEN TO ALL PATIENTS. THE ADDUCTOR CANAL BLOCK WAS GIVEN TO ALL PATIENTS JUST AFTER COMPLETION OF SURGERY. IN THE POSTOPERATIVE WARD, PATIENT WAS GIVEN INJECTION ACETAMINOPHEN 6 HOURLY FOR FIRST 24 H. TABLET PARACETAMOL 650 MG THRICE A DAY AND ACECLOFENAC 100 MG TWICE DAILY WAS GIVEN TO ALL PATIENTS DURING THE HOSPITAL STAY TILL DISCHARGE. -IN 10 PATIENTS IN GROUP A AND 11 PATIENTS IN GROUP B, BLOOD TRANSFUSIONS WERE NEEDED FOLLOWING TKA. -4 PATIENTS IN GROUP A AND 7 PATIENTS IN GROUP B HAD THIGH ECCHYMOSIS AT DISCHARGE; NO INTERVENTION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804050 UNKNOWN KNEE CONSTRUCT SIGMA KNEE CONSTRUCT JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention