BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA FEM ADAPTER 7 DEGREE

    MDR report key: 21314664 · Received February 5, 2025

    Report

    Report Number
    1818910-2025-02194
    Event Type
    Injury
    Date Received
    February 5, 2025
    Date of Event
    January 22, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295233923
    PMA / PMN Number
    K060515
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. 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). INVESTIGATION SUMMARY: LEFT KNEE REVISION FOR FAILED REVISION ARTHROPLASTY. SIGMA TC3 FEMUR WITH 7 DEGREE ADAPTER, ADAPTER BOLT, FULL POROUS UNIVERSAL SLEEVE, AND UNIVERSAL STEM. ADAPTER BOLT AND ADAPTER BROKEN. ADAPTER WAS NOT ABLE TO BE REMOVED FROM UNIVERSAL SLEEVE. SURGERY HAD TO BE ABORTED AND PATIENT TRANSFERRED TO ANOTHER FACILITY. THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT (NO SUBJECT).ZIP. THE X-RAY INVESTIGATION REVEALED THAT THE SIGMA FEM ADAPTER 7 DEGREE WAS SLIGHTLY OFF-AXIS, LIKELY CAUSED BY THE FRACTURE OF THE SIG FEM ADAP +2/-2 OFFSET BOLT. HOWEVER, NO FRACTURE OF THE SIGMA FEM ADAPTER 7 DEGREE COULD BE SEEN. ADDITIONALLY, THERE IS NOTHING INDICATIVE OF A DEVICE NONCONFORMANCE THAT COULD HAVE BEEN RELATED TO AN INABILITY TO DISASSEMBLE THE MATING COMPONENT AS INTENDED. FUNCTIONALITY ISSUES CANNOT BE ASSESSED THROUGH A PHOTO INVESTIGATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 960782 LOT NUMBER: 599413, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE SIGMA FEM ADAPTER 7 DEGREE WOULD NOT HAVE CONTRIBUTED 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: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 960782 LOT NUMBER: 599413, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED A LEFT KNEE REVISION FOR FAILED REVISION ARTHROPLASTY. ADAPTER BOLT AND ADAPTER BROKEN. ADAPTER WAS NOT ABLE TO BE REMOVED FROM UNIVERSAL SLEEVE. THE SURGEON TRIED FOR 90 MINUTES TO REMOVE THE ADAPTER FROM THE SLEEVE BUT WAS UNSUCCESSFUL. THE SURGEON DECIDED TO TRANSFER THE PATIENT TO ANOTHER FACILITY FOR TREATMENT AND MOST LIKELY A DISTAL FEMORAL REPLACEMENT. PROCEDURE WAS NOT COMPLETED SUCCESSFULLY AND HAD TO BE ABORTED AND PATIENT TRANSFERRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363279 SIGMA FEM ADAPTER 7 DEGREE SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY JWH DEPUY ORTHOPAEDICS INC US 599413 10603295233923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention PFC*SIGMA TC3 FEM LEFT SZ4| SIG FEM ADAP +2/-2 OFFSET BOLT| UNIVERSAL FEM SLV FUL POR 40MM