BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE CONSTRUCT SIGMA

    MDR report key: 24511951 · Received March 4, 2026

    Report

    Report Number
    1818910-2026-04110
    Event Type
    Injury
    Date Received
    March 4, 2026
    Date of Event
    July 14, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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. DEVICE HISTORY LOT: THE DEVICE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. ADDED: D10 CONCOMITANT.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: ROY A., PANDEY R.K., DABAS R. LOWER TOURNIQUET CUFF PRESSURE REDUCES POSTOPERATIVE THIGH PAIN IN OBESE PATIENTS UNDERGOING TOTAL KNEE ARTHROPLASTY. INTERNATIONAL JOURNAL OF LIFE SCIENCES, BIOTECHNOLOGY AND PHARMA RESEARCH VOL. 14, NO. 7, JULY 2025. DOI: 10.69605/IJLBPR_14.7.2025.112 (PUBMED CITATION NOT AVAILABLE). OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS PROSPECTIVE RANDOMIZED STUDY WAS TO EVALUATE THE RESULTS OF THE LIMB OCCLUSION PRESSURE TECHNIQUE IN THE APPLICATION OF TOURNIQUETS TO A SUBSET OF OBESE PATIENTS WHO WERE UNDERGOING TOTAL KNEE ARTHROPLASTY (TKA). A TOTAL OF 40 PATIENTS WHO UNDERWENT PRIMARY UNILATERAL TKA WERE INCLUDED IN THE STUDY. TWENTY PATIENTS WERE ASSIGNED TO THE LIMB OCCLUSION PRESSURE (LOP) GROUP, AND TWENTY WERE ASSIGNED TO THE CONTROL GROUP. THERE WERE 8 MALES AND 12 FEMALES IN LOP GROUP WHILE 5 MALES AND 15 FEMALES IN CONTROL GROUP. THE MEAN AGE WAS 64±6 AND 64±6.5 YEARS, RESPECTIVELY. ALL PATIENTS RECEIVED CEMENTED IMPLANTS FROM THE DEPUY SYNTHES PFC® SIGMA® KNEE SYSTEM (WARSAW, IN, USA). THE ORTHOPEDIC DIAGNOSTIC CENTRE CONDUCTED WOUND INSPECTIONS AND DETECTED ANY POSTOPERATIVE COMPLICATIONS AT EACH VISIT FOR ALL PATIENTS AT ONE, TWO, AND SIX MONTHS POSTOPERATIVELY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES PFC® SIGMA® KNEE SYSTEM. OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: CEMENT (UNKNOWN MANUFACTURER). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT SIGMA (QTY 29): (N=9) REQUIRED BLOOD TRANSFUSION. (N=7) DEVELOPED MINOR BLISTERING OR OTHER PRESSURE-RELATED INJURIES, SUCH AS MODERATE ECCHYMOSIS, UNDER THE TOURNIQUET CUFF APPLICATION SITE. NO INTERVENTION REPORTED. (N=13) EXPERIENCED SOME OOZING FROM THE INCISION SITE. NO INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328162 UNKNOWN KNEE CONSTRUCT SIGMA PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention CEMENT (UNKNOWN MANUFACTURER)