BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK KNEE TIBIAL INSERT SIGMA

    MDR report key: 21857000 · Received April 17, 2025

    Report

    Report Number
    1818910-2025-05860
    Event Type
    Injury
    Date Received
    April 17, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. H3, H6: 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. 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. 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: KIM S, YANG J, MOON S, CHOI S. WILL MOBILE-BEARING TOTAL KNEE ARTHROPLASTY BE LOST TO HISTORY? A COMPARATIVE STUDY OF LONG-TERM FOLLOW-UP. LIFE (BASEL). 2024 OCT 21;14(10):1344. DOI: 10.3390/LIFE14101344. PMID: 39459644; PMCID: PMC11509738. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY WAS TO COMPARE THE CLINICAL AND RADIOLOGIC OUTCOMES OF MB AND FB TKA AFTER APPROXIMATELY 13 YEARS OF FOLLOW-UP. FROM JULY 2007 TO DECEMBER 2010, 107 PATIENTS WHO UNDERWENT PRIMARY TKA FOR OSTEOARTHRITIS (OA) AT JEJU NATIONAL UNIVERSITY HOSPITAL (JNUH) USING THE SAME PERIOPERATIVE PROTOCOL WERE REVIEWED FOR THIS STUDY. ALL OPERATIONS WERE PERFORMED BY ONE OF TWO SENIOR ORTHOPEDIC SURGEONS USING ONE OF THESE INSTRUMENT SYSTEMS, THE NEXGEN LPS-FLEX (ZIMMER INC., WARSAW, IN, USA) OR THE PFC SIGMA RP-F MOBILE (DEPUY ORTHOPAEDICS INC., WARSAW, IN, USA), ALL OF WHICH INCLUDED POSTERIOR CRUCIATE SUBSTITUTING (PS)-TYPE IMPLANTS FIXED WITH CEMENT. THERE WERE 43 HAD UNDERGONE TKA WITH A FIXED-BEARING INSERT, AND 45 HAD A MOBILE-BEARING INSERT (FIGURE 1). THE MEAN FOLLOW-UP WAS 13.6 YEARS (13.49 ± 1.91 YEARS FOR THE FB GROUP, AND 13.84 ± 1.46 YEARS FOR THE MB GROUP). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: PFC SIGMA RP-F MOBILE ; DEPUY ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE TIBIAL TRAY SIGMA (QTY.2 ) 2 PATIENTS HAD AN ASEPTIC LOOSENING OF THE TIBIAL COMPONENT AND BOTH THE CASES SUBSEQUENTLY UNDERWENT REVISION TKA. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE CONSTRUCT SIGMA (QTY.2 ) 2 PATIENTS HAD OSTEOLYSIS; NO TREATMENT WAS INDICATED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK KNEE TIBIAL INSERT SIGMA (QTY.1) 1 PATIENT HAD POLYETHYLENE WEAR ; REQUIRED THE PE TO BE CHANGED AND REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682250 UNK KNEE TIBIAL INSERT SIGMA KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention