BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIG RPF INS SZ 5 10MM

    MDR report key: 10836429 · Received November 13, 2020

    Report

    Report Number
    1818910-2020-24556
    Event Type
    Injury
    Date Received
    November 13, 2020
    Date of Event
    May 23, 2015
    Report Date
    October 28, 2020
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    NJL
    UDI-DI
    10603295230458
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. 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). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: DHR REVIEW WAS CONDUCTED ON THE PFC SIG RPF INS SZ 5 10MM (PRODUCT CODE 951050, LOT NUMBER 622303). DHR REVIEW (B)(4), (PRODUCT CODE 951050, LOT NUMBER 622303). DHR REVIEWED - NO DEVIATIONS OR NONCONFORMANCES WERE NOTED.

    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: ADDED: B5, B6 AND D4. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. CORRECTED: B3.

    Description of Event or Problem · 0

    CLINICAL COMPLAINT (B)(4). LEFT KNEE REVISED ON (B)(6) 2015, DUE TO SPIN-OUT. ORIGINAL SURGERY DUE TO OSTEOARTHRITIS.

    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

    SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR POLYETHYLENE ROTATED/ SPIN OUT. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2015, DATE OF EVENT (ONSET): (B)(6) 2015, (LEFT KNEE). TREATMENT: LEFT KNEE REVISION ON (B)(6) 2015 - TIBIAL INSERT REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300636 PFC SIG RPF INS SZ 5 10MM PFC SIGMA RP-F : KNEE TIBIAL INSERT NJL DEPUY INTERNATIONAL LTD - 8010379 95-1050 622303 10603295230458

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention DEPUY CMW 2G 40G.| DEPUY DUOFIX MBT TRAY SZ 6.| PFC*SIGMA/OV/DOME PAT 3PEG,38.| SIG PS150 FEM COMP SZ 5 L.