BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE CONSTRUCT SIGMA

    MDR report key: 20127680 · Received September 3, 2024

    Report

    Report Number
    1818910-2024-18558
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    January 1, 2024
    Report Date
    September 3, 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: KANNA R, KUMAR VS, KARTHIKEYAN V, ANAND S, RAVICHANDRAN C, MURALI SM. INFLUENCE OF PREOPERATIVE DEFORMITY ON FLEXION GAP ASYMMETRY IN MEASURED RESECTION TECHNIQUE: A THEORETICAL STUDY IN NAVIGATED GAP BALANCING TOTAL KNEE ARTHROPLASTIES, DONE FOR VARUS KNEE OSTEOARTHRITIS. J AM ACAD ORTHOP SURG GLOB RES REV. 2024 FEB 14;8(2):E23.00082. DOI: 10.5435/JAAOSGLOBAL-D-23-00082. PMID: 38354198; PMCID: PMC11136515. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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.

    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. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KANNA R, KUMAR VS, KARTHIKEYAN V, ANAND S, RAVICHANDRAN C, MURALI SM. INFLUENCE OF PREOPERATIVE DEFORMITY ON FLEXION GAP ASYMMETRY IN MEASURED RESECTION TECHNIQUE: A THEORETICAL STUDY IN NAVIGATED GAP BALANCING TOTAL KNEE ARTHROPLASTIES, DONE FOR VARUS KNEE OSTEOARTHRITIS. J AM ACAD ORTHOP SURG GLOB RES REV. 2024 FEB 14;8(2):E23.00082. DOI: 10.5435/JAAOSGLOBAL-D-23-00082. PMID: 38354198; PMCID: PMC11136515. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS STUDY IS TO ASKS THE FOLLOWING: (1) WHAT IS THE (A) CALCULATED FGA AND (B) THEORETICAL RISK OF A >2° AND >3° FGA, IF THE PFC IS PLANNED BASED ON EACH OF THE THREE INTRAOPERATIVE METHODS OF MR TECHNIQUE ,THAT IS, 3° ER TO THE PCL, PARALLEL TO THE SEA, AND PERPENDICULAR TO THE WL, IN TKAS DONE FOR VKO? (2) DOES THE SEVERITY OF PREOPERATIVE DEFORMITY INFLUENCE A) FGA AND B) THE RISK OF A >2° AND >3° FGA, IF THE PFC IS PLANNED BASED ON EACH OF THE ABOVEMENTIONED THREE MR METHODS, IN TKAS DONE FOR VKO? BETWEEN JANUARY 2017 AND MARCH 2020, A TOTAL OF 216 PATIENTS (177 FEMALE AND 39 MALE) WITH A MEAN AGE OF 66.5 ± 8.2 YEARS (RANGE 44¿89 YEARS). A STANDARD MEDIAL PARAPATELLAR APPROACH WAS USED IN ALL CASES. PFC SIGMA (DEPUY ORTHOPAEDICS) CEMENTED FIXED BEARING, POSTERIOR CRUCIATE-SUBSTITUTING IMPLANT WAS USED, AND THE PATELLA WAS RESURFACED IN ALL PATIENTS. FOLLOW-UP WAS UNKNOWN. 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 19): ANTERIOR FEMORAL NOTCHING WAS PRESENT IN 18 OF 321 KNEES (5.6%). NO INTERVENTION NOTED. ONE PATIENT DEVELOPED A DEEP INFECTION IN ONE OF THE KNEES 3 WEEKS AFTER SURGERY, WHICH WAS TREATED BY DÉBRIDEMENT AND EXCHANGE OF THE POLYETHYLENE INSERT AND RECOVERED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736091 UNKNOWN KNEE CONSTRUCT SIGMA KNEE CONSTRUCT JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention