BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA C/R NPOR FEM RT SZ 3

    MDR report key: 15500601 · Received September 28, 2022

    Report

    Report Number
    1818910-2022-18926
    Event Type
    Injury
    Date Received
    September 28, 2022
    Date of Event
    September 9, 2022
    Report Date
    September 28, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295232025
    PMA / PMN Number
    K943462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (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 THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED. PHOTO EVIDENCE AND X-RAYS PROVIDED WERE REVIEWED AND FOUND NO IMPLANT ISSUE. THE REPORTED CONDITIONS WERE NOT CONFIRMED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT CODE 960013/LOT CODE 2365525 COMBINATION. BASED ON THE INABILITY TO FIND ANY NC¿S AGAINST THE PROVIDED PRODUCT CODE 960013/LOT CODE 2365525 COMBINATION, IT IS REASONABLE TO CONCLUDE THAT THERE ARE NO ANOMALIES WITH REGARD TO MANUFACTURING OR INSPECTION CONTAINED IN THE DEVICE HISTORY RECORDS THAT WOULD CONTRIBUTE TO THE REPORTED EVENT.

    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. H10 ADDITIONAL NARRATIVE: 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

    CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2007; DATE OF REVISION: (B)(6) 2022; (RIGHT KNEE). TREATMENT: REVISION; FEMORAL AND TIBIAL COMPONENTS WERE REMOVED.

    Description of Event or Problem · 0

    OFFICE NOTE (B)(6) 2022: PATIENT IS HAVING PAIN AND FEELINGS OF INSTABILITY IN HER RIGHT KNEE WHICH FEELS LIKE HER ¿LEG IS SHIFTING ON HER WHEN SHE WALKS.¿ SHE HAS DIFFICULTY WITH ACTIVITIES OF DAILY LIVING. SHE HAS MODERATE EFFUSION AND FLEXION ONLY TO 60-70 DEGREES WITH SIGNIFICANT VARUS LAXITY. RADIOGRAPHS SHOW KNEE IS IN MORE VARUS ALIGNMENT WHEN COMPARED TO PREVIOUS RADIOGRAPHS WITH SOME COLLAPSE. PATELLA SHOWS SOME LYTIC DYSVASCULAR CHANGES. (B)(6) 2022: REVISION PERFORMED ON REVISION COMPONENTS IN THE RIGHT KNEE. PLEASE NOTE, THE RECORDS INDICATE THIS PATIENT UNDERWENT A REVISION OF REVISION COMPONENTS. THERE IS NO INFORMATION PROVIDED THAT INDICATES THE MANUFACTURER OF THE PRIMARY COMPONENTS PRIOR TO THE FIRST REVISION. INTRAOPERATIVE FINDINGS STATE THAT THE FEMORAL ADAPTOR HAD FRACTURED. THERE WAS MASSIVE DISTAL FEMORAL OSTEOLYSIS AND MASSIVE PROXIMAL TIBIAL LYSIS REQUIRING SIGNIFICANT BONE GRAFTING. THERE WAS FAIRLY SIGNIFICANT SYNOVITIS SECONDARY TO METALLOSIS. THE FEMORAL COMPONENT WAS ROTATING AND WAS LOOSE-NO INTERFACE PROVIDED. IT COULD BE PUSHED INTO VARUS AND VALGUS STRESS BUT COULD NOT BE DISIMPACTED FROM THE SLEEVE. THE FEMORAL ADAPTOR WAS BROKEN BUT STILL HAD THE THREADS ENGAGED IN THE METAPHYSEAL SLEEVE THAT COULD NOT BE DISIMPACTED. ULTIMATELY THE SURGEON WAS ABLE TO DISRUPT THE TAPER AND REMOVE THE FEMORAL COMPONENT. HE CHOSE TO LEAVE THE METAPHYSEAL SLEEVE AND PLACED A HINGED NOILES DISTAL FEMORAL REPLACEMENT. PATELLA WAS WORN AND REMOVED WITH THE SURGEON CHOOSING NOT TO RESURFACE DUE TO LACK OF BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076558 PFC*SIGMA C/R NPOR FEM RT SZ 3 SIGMA KNEE PRIMARY : KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US 96-0013 2365525 10603295232025

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention MBT CEM KEEL TIB TRAY SZ3| PFC SIGMARP CV TB/IN S3 12.5| PFC SIGMARP CV TB/IN S3 12.5| PFC*SIGMA/OV/DOME PAT 3PEG,38| UNK KNEE FEMORAL ADAPTOR LPS