BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA CRVD GVF INS 3 8MM

    MDR report key: 13175441 · Received January 6, 2022

    Report

    Report Number
    1818910-2022-00299
    Event Type
    Injury
    Date Received
    January 6, 2022
    Date of Event
    January 1, 2021
    Report Date
    January 6, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    PMA / PMN Number
    K033272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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: EXAMINATION OF THE RETURNED DEVICE FOUND PITTING ON THE SURFACE IN CONTACT WITH THE FEMORAL COMPONENT. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WERE PERFORMED FOR THE FINISHED DEVICE DHR158113008/D18121102, IT WAS MANUFACTURED ON 07-DEC-2018. EXPIRY DATE IS 30-NOV-2023. 48 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION, AND NO NON-CONFORMANCES WERE IDENTIFIED, IFU-0902-00-252. DEVICE HISTORY REVIEW: 48 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION, AND NO NON-CONFORMANCES WERE IDENTIFIED. CORRECTED: H3

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT : A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED.

    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.

    Description of Event or Problem · 0

    SURGEON IS REPORTING A KNEE-TEP REVISION OF A PFC SIGMA PROSTHESIS AFTER ABOUT 3 YEARS OF IMPLANTATION BECAUSE OF HIGH BONE LOSS IN THE PATIENT. REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO INSTABILITY, PAIN, EFFUSION, DECREASED RANGE OF MOTION, CHRONIC SYNOVITIS AND OSTEOLYSIS. UPON ENTERING THE JOINT, THE TIBIAL AND FEMORAL COMPONENTS WERE NOTED TO BE LOOSE ¿ INTERFACE NOT PROVIDED. TIBIA, FEMORAL AND INSERT COMPONENTS WERE REVISED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON, COMPETITOR PRODUCTS WERE IMPLANTED. DOI: 2018, DOR: (B)(6) 2021. UNKNOWN SIDE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172436 SIGMA CRVD GVF INS 3 8MM SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US D18121102
    740134 SIGMA CRVD GVF INS 3 8MM SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US D18121102

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention PFC SIGMA TIB TRAY CEM SZ3| UNK KNEE FEMORAL SIGMA| UNK KNEE TIBIAL TRAY SIGMA