BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA C/R POR FEM LF SZ4

    MDR report key: 8925807 · Received August 23, 2019

    Report

    Report Number
    1818910-2019-102069
    Event Type
    Injury
    Date Received
    August 23, 2019
    Date of Event
    August 5, 2019
    Report Date
    August 26, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    PMA / PMN Number
    K943462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RECEIVED FOR EXAMINATION. 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 : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. 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 THAT THE FEMUR SUBLIMED ANTERIORLY OFF OF THE TIBIA. THE PCL WAS NO LONGER FUNCTIONAL AND THE FEMUR WAS ABLE TO SUBLUXATION OFF OF THE ANTERIOR PORTION OF THE TIBIA.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 · 1

    REVISION KNEE REPLACEMENT: MR (B)(6), (B)(6) HOSPITAL, (B)(6) 2019. THE PATIENT UNDERWENT PRIMARY TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2008. WAS REPORTEDLY HAPPY UP UNTIL A WEEK AGO WHEN THE KNEE BECAME "UNSTABLE" AND THE FEMUR SUBLUXED OFF OF THE TIBIA. FOLLOWING AN EVALUATION OF THE PATIENT, MR RADIC ELECTED TO REVISE THE KNEE FROM A CR TO PS OPTION. NO DELAY IN SURGERY. PATIENT INITIALS, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720143 PFC*SIGMA C/R POR FEM LF SZ4 SIGMA KNEE PRIMARY : KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US 2970024B

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention