BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*SIGMA/OV/DOME PAT 3PEG,35

    MDR report key: 9418520 · Received December 5, 2019

    Report

    Report Number
    1818910-2019-121003
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Date of Event
    November 12, 2019
    Report Date
    November 12, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295232612
    PMA / PMN Number
    K961685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 : DEVICE REVIEWED. NO MANUFACTURING OR PRODUCT DESIGN ISSUE IDENTIFIED. ROOT CAUSE UNDETERMINED. 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 : PRODUCT CODE 960101, LOT NO. D19061826 WAS MANUFACTURED ON 20-JUN-2019. (B)(4) PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE: COMPROMISED STERILITY.

    Description of Event or Problem · 1

    DURING KNEE SURGERY WHEN OPENING THE PATELLA IMPLANT -35, IT WAS SEEN THAT THE STERILIZATION SAFETY WRAP WAS OPEN, AS THE IMPLANT WAS NOT USED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO. ACTION TAKEN WHEN EVENT OCCURRED? --> ANOTHER IMPLANT WAS USED. WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES. WERE FRAGMENTS GENERATED? --> NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212221 PFC*SIGMA/OV/DOME PAT 3PEG,35 SIGMA KNEE PRIMARY : KNEE PATELLA JWH DEPUY ORTHOPAEDICS INC US 96-0101 D19061826 10603295232612

    Patients

    Seq Age Sex Outcome Treatment
    1