BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG PS150 FEM COMP SZ 4N L

    MDR report key: 12278611 · Received August 4, 2021

    Report

    Report Number
    1818910-2021-17084
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    January 24, 2013
    Report Date
    July 15, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    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). 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 :THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    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

    CLINICAL ADVERSE EVENT RECEIVED FOR CREPITUS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS PROBABLY RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2012, DATE OF EVENT (ONSET): (B)(6) 2013, (LEFT KNEE). TREATMENT: SURGICAL INTERVENTION - ARTHROSCOPY (NO PRODUCTS REVISED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175083 SIG PS150 FEM COMP SZ 4N L SIGMA KNEE PRIMARY : KNEE FEMORAL JWH DEPUY IRELAND - 9616671 FP9AM4

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention MBT CEM KEEL TIB TRAY SZ3| PFC SIG RPF INS SZ 4 10MM| PFC*SIGMA/OV/DOME PAT 3PEG,35| SIG PS150 FEM COMP SZ 4N L| MBT CEM KEEL TIB TRAY SZ3| PFC SIG RPF INS SZ 4 10MM| PFC*SIGMA/OV/DOME PAT 3PEG,35| SIG PS150 FEM COMP SZ 4N L