BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10600978 · Received September 29, 2020

    Report

    Report Number
    1818910-2020-21110
    Event Type
    Injury
    Date Received
    September 29, 2020
    Report Date
    September 16, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295232612
    PMA / PMN Number
    K961685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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: PRODUCT CODE 960101, WORK ORDER (B)(4) WAS MANUFACTURED ON 07-JAN-2019. 35 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. NR-0115853 WAS ASSOCIATED WITH THIS LOT. THE NR INVESTIGATED A TOOL ISSUE IN THE POLY VALUE STREAM. THERE WAS NO CORRELATION BETWEEN THIS AND THE ISSUE IN THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (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

    IT WAS REPORTED BY THE PATIENT THAT SHE HAD A TOTAL KNEE REPLACEMENT AND SCHEDULED FOR ARTHROSCOPIC SURGERY ON (B)(6), TO SEE OF THERE IS ANYTHING THAT CAN BE DONE TO EASE THE PAIN AND IMPROVE HER RANGE OF MOTION, WHICH IS ONLY 90 DEGREES AND POSSIBLE ALLERGY TO NICKLE. THE CUSTOMER ALSO MENTIONED THAT SHE MADE A CONTACT THROUGH EMAIL ABOUT THREE TIMES BUT RECEIVED NO RESPONSE. DOI: (B)(6) 2019 : DOR: NONE REPORTED (UNK KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066362 PFC*SIGMA/OV/DOME PAT 3PEG,35 SIGMA KNEE PRIMARY : KNEE PATELLA JWH DEPUY ORTHOPAEDICS INC US 96-0101 9003890 10603295232612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DEPUY1 GENTAMICIN CEMENT 40G| SIG MOD TIB TRAY CEM COCR 3| SIGMA CR150 CEM SZ 3 RT| SIGMA XLK CVD PLUS INS 3 10MM| DEPUY1 GENTAMICIN CEMENT 40G| SIG MOD TIB TRAY CEM COCR 3| SIGMA CR150 CEM SZ 3 RT| SIGMA XLK CVD PLUS INS 3 10MM