BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIG RPF INS SZ 4 10MM

    MDR report key: 20558651 · Received October 29, 2024

    Report

    Report Number
    1818910-2024-22562
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    October 16, 2024
    Report Date
    October 29, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NJL
    UDI-DI
    10603295230410
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: REVISION OF A PFC SIGMA FROM [YEAR]. REASON FOR REVISION WAS DUE TO POLY WEAR. FEMORAL, TIBIAL, AND PATELLA IMPLANTS WERE NOT REVISES AS THEY WERE WELL FIXED. POLY DEBRIS WAS REMOVED AND THE AREA WAS THOROUGHLY CLEANED. NO INDICATION OF WEAR ON THE FEMORAL OR TIBIAL COMPONENTS. PATIENT LEFT SIDE. THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT(B)(4). THE PHOTO INVESTIGATION FOUND WEAR, AND DAMAGE CONSISTENT WITH 19 YEARS OF SERVICE WITH ARTICULAR LOADING WITHIN ANTICIPATED REGIONS OF THE INSERT. THE POSTERIOR-MEDIAL PORTION OF THE INSERT WAS DAMAGED, CONSISTENT WITH ROTATION BETWEEN THE FEMORAL COMPONENT AND THE MATING ARTICULAR PORTIONS OF THE TIBIAL INSERT. 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 CONFIRMED AS THE OBSERVED CONDITION OF THE PFC SIG RPF INS SZ 4 10MM WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS AND THE PROVIDED INFORMATION, A POTENTIAL CAUSE WAS NOT ESTABLISHED AND 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 BELOW AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. PRODUCT CODE: 951040. LOT NUMBER: ZP8PG4000. 1) QUANTITY MANUFACTURED: 11. 2) DATE OF MANUFACTURE: 4/25/2005. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE. 4) EXPIRY DATE: 4/24/2010. 5) IFU-0902-00-769.

    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

    REVISION OF A PFC SIGMA. REASON FOR REVISION WAS DUE TO POLY WEAR. FEMORAL, TIBIAL, AND PATELLA IMPLANTS WERE NOT REVISES AS THEY WERE WELL FIXED. POLY DEBRIS WAS REMOVED AND THE AREA WAS THOROUGHLY CLEANED. NO INDICATION OF WEAR ON THE FEMORAL OR TIBIAL COMPONENTS. PATIENT LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322192 PFC SIG RPF INS SZ 4 10MM PFC SIGMA RP-F : KNEE TIBIAL INSERT NJL DEPUY ORTHOPAEDICS INC US ZP8PG4000 10603295230410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention