BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIG RPF INS SZ 5 10MM

    MDR report key: 13266320 · Received January 17, 2022

    Report

    Report Number
    1818910-2022-00978
    Event Type
    Injury
    Date Received
    January 17, 2022
    Date of Event
    May 15, 2015
    Report Date
    January 17, 2022
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    NJL
    UDI-DI
    10603295230458
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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 : DHR REVIEW WAS PERFORMED AS PART OF (B)(4). DHR WAS REVIEWED FOR PRODUCT CODE 951050, WORK ORDER /LOT NO. (B)(4) AND NO DEVIATIONS WERE NOTED.

    Description of Event or Problem · 0

    (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR LOSS OF MOVEMENT IN KNEE POST TOTAL KNEE REPLACEMENT. NEEDED MANIPULATION UNDER ANAESTHETIC: ADHESIONS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2015. DATE OF EVENT (ONSET): (B)(6) 2015. (LEFT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA, CELESTONE & NAROPIN INJECTION, PHYSIOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857908 PFC SIG RPF INS SZ 5 10MM PFC SIGMA RP-F : KNEE TIBIAL INSERT NJL DEPUY IRELAND 9616671 95-1050 581291 10603295230458

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention DEPUY CMW 2G 40G| DEPUY DUOFIX MBT TRAY SZ 4.5| PFC SIG RPF INS SZ 5 10MM| PFC*SIGMA/OV/DOME PAT 3PEG,38| SIG PS150 FEM COMP SZ 5 L