BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFCSIG CEM FEM STEM 5DG13X90MM

    MDR report key: 21302620 · Received February 4, 2025

    Report

    Report Number
    1818910-2025-02009
    Event Type
    Injury
    Date Received
    February 4, 2025
    Date of Event
    November 6, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Product Problem
    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). INVESTIGATION SUMMARY: USER REPORT RECEIVED BFARM CASE (B)(4). IN THE ABOVE-MENTIONED PARTIALLY COUPLED, CEMENTED REVISION PROSTHESIS, A FRACTURE OF THE FEMORAL STEM AND THE CONNECTING SCREW OCCURRED WITHOUT TRAUMA. FEMORAL STEM AND THE CONNECTING SCREW IN THE CONNECTION AREA TO THE FEMORAL SHIELD. THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT THE DISTAL PORTION OF THE PFCSIG CEM FEM STEM 5DG13X90MM HAS FRACTURED ABOVE THE COLLAR. ADDITIONALLY, NO SIGNS OF BURNISHING THAT SUGGEST MICROMOTION CAN BE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [960720/ 350153R], AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. ALTHOUGH A DEFINITIVE CAUSE FOR DEVICE FRACTURE IS NOT ESTABLISHED, ONE CONTRIBUTING FACTOR APPEARS TO BE LOOSENING AT THE INTERFACE BETWEEN THE CEMENT AND BONE. THE SPECIFIC MANUFACTURER OF THE CEMENT REMAINS UNKNOWN; HOWEVER, IT IS EVIDENT THAT AN EXCESS AMOUNT OF CEMENT WAS USED TO FILL BONE VOIDS IN THE ANTERIOR PORTION OF THE DISTAL FEMORAL HEAD. THIS LIKELY RESULTED IN INADEQUATE FIXATION BETWEEN THE CEMENT AND THE BONE. INSUFFICIENT FIXATION CAN LEAD TO MICROMOTION, WHICH MAY INCREASE STRESS AT THE JUNCTION OF THE STEM BOLT AND THE STEM. THIS CAN RESULT IN FATIGUE CRACKS AND ULTIMATELY CATASTROPHIC FAILURE. 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 PFCSIG CEM FEM STEM 5DG13X90MM WOULD 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: 1) QUANTITY MANUFACTURED: (B)(4). 2) DATE OF MANUFACTURE: 2007-05. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NONE. 4) EXPIRY DATE: 2017-05. 5) IFU REFERENCE: IFU-0902-00-252. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [960720/ 350153R], AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. CORRECTED: H4, H6.

    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. H11 ADDITIONAL NARRATIVE: ADDED: B5, D6A, D10, G4, H4 AND H6 (HEALTH EFFECT - CLINICAL CODE). CORRECTED: D1, D2, D4 (LOT, CATALOG, EXPIRATION DATE, UDI) AND H6 (MEDICAL DEVICE PROBLEM CODE). 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. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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

    ADDITIONAL INFORMATION RECEIVED DESCRIBES A REVISION PROCEDURE REQUIRING EXTENSIVE DEBRIDEMENT. EXTENSIVE BONE EROSION WAS NOTED ON THE MEDIAL AND LATERAL FEMORAL CONDYLES AS WELL AS ALONG THE MEDIAL TIBIAL PLATEAU REQUIRING BONE GRAFTING TO CORRECT. GRANULATION TISSUE INDICATIVE OF LOOSENING WAS NOTED. THE FEMORAL AND TIBIAL SIDES WERE NOTED TO BE LOOSE - INTERFACE NOT IDENTIFIED. THE PATELLA WAS REMOVED AND UNDERNEATH SMALL CYSTS WERE IDENTIFIED AND REMOVED BEFORE REPLACING. THIS IS THE RIGHT SIDE. THE DATE OF OPERATION FOR THE FIRST IMPLANTATION WAS ON (B)(6) 2008, WITHOUT COMPLICATIONS. THE REVISION WENT SMOOTHLY. THE CONNECTING SCREW BETWEEN THE FEMORAL SHIELD AND THE FEMORAL SHAFT IS AFFECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN A PARTIALLY COUPLED, CEMENTED REVISION PROSTHESIS, A FRACTURE OF THE FEMORAL STEM AND THE CONNECTING SCREW OCCURRED WITHOUT TRAUMA IN THE CONNECTION AREA TO THE FEMORAL SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159330 PFCSIG CEM FEM STEM 5DG13X90MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH DEPUY ORTHOPAEDICS INC US 350153R

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention BIOSTOP G CEM RESTR 12MM| PFC SIGMA FEM POST AUG SZ3 4MM| PFC SIGMA TIB TRAY CEM SZ3| PFC*SIGMA DIS AUG 4MM,SZ3,RGHT| PFC*SIGMA DIS AUG 4MM,SZ3,RGHT| PFC*SIGMA TC3 FEM RT SZ3| PFC*SIGMA TC3 INS 22.5MM, SZ 3| PFC*SIGMA/OV/DOME PAT 3PEG,38| PFCSIG +/-2FEMOFFSET STMBLT| PFCSIG CEM FEM STEM 5DG13X90MM| SIG TIB CEM STM 13X60 2/2.5/3