BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA XLKCVD PLUS INS 4 12.5MM

    MDR report key: 20369084 · Received October 4, 2024

    Report

    Report Number
    1818910-2024-20835
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    September 25, 2024
    Report Date
    October 4, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295250623
    PMA / PMN Number
    K040166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, ¿PFC SIGMA INSERT WAS NOT NORMAL LOOKING, IT HAS SOME EXTRA PLASTIC IN IMPLANT¿. THE PRODUCT RETURNED TO MEDTECH ORTHOPAEDICS FOR EVALUATION. THE MEDTECH ORTHOPAEDICS TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SIGMA XLKCVD PLUS INS 4 12.5MM REVEALED THAT A PORTION OF THE BOTTOM SURFACE WAS DELAMINATED. FURTHERMORE, ONE (1) OF THE TWO (2) FRONTAL LOCKING FEATURES EXHIBITS SIGNS OF DAMAGE/DEFORMATION. SCRATCHES WERE ALSO OBSERVED ON THE BACKSIDE AND ONE OF THE POSTERIOR GROOVES THAT ARE DESIGNED TO SLIDE INTO THE LOCKING FEATURE OF THE MATING TIBIAL TRAY WAS DEFORM. EVIDENCE SUGGESTS UNSUCCESSFUL INSERTION ATTEMPTS DURING THE SURGICAL PROCESS, RESULTING IN THE DAMAGE FOUND AFTER VISUAL INSPECTION. THE GEOMETRY OF THE INSERT IS DESIGNED IN SUCH A WAY THAT, THE IMPLANT SHOULD BE SLID INTO THE TIBIAL TRAY STARTING AT THE ANTERIOR EDGE BY ENGAGING BOTH SIDES OF THE INSERT INTO THE TIBIAL TRAY AND THEN APPLYING A POSTERIORLY DIRECTED FORCE UNTIL SEATED. THE DEFORMATION / DAMAGE SUGGESTS THE FORCE WAS APPLIED POSTERIORLY BEFORE THE INSERT IS FULLY SLID INTO TIBIAL TRAY. FUNCTIONAL TESTING WAS NOT PERFORMED AS THE MATING TIBIAL TRAY COMPONENT WAS NOT RETURNED. ADDITIONALLY, DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [PRODUCT CODE: 970462 / LOT NUMBER: M45G86] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE SIGMA XLKCVD PLUS INS 4 12.5MM WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 09-08-2023. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE. 4) EXPIRY DATE: 08-31-2028. 5) IFU-0902-00-252. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [PRODUCT CODE: 970462 / LOT NUMBER: M45G86] NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, 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). 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

    ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE WAS THE RIGHT KNEE.

    Description of Event or Problem · 0

    PFC SIGMA INSERT WAS NOT NORMAL LOOKING, IT HAS SOME EXTRA PLASTIC IN IMPLANT. ADDITIONAL EVENT INFORMATION: CUSTOMER CLAIMED THAT EXTRA PLASTIC BIT WENT OFF FROM INSERT AND THEY COULD NOT FIND IT ANYWHERE. SO THAT IS WHY THE INSERT FAILED TO ADJUST TO THE TIBIAL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443001 SIGMA XLKCVD PLUS INS 4 12.5MM SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US M45G86 10603295250623

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown