BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG PS150 FEM COMP SZ 4N L

    MDR report key: 13288705 · Received January 19, 2022

    Report

    Report Number
    1818910-2022-01154
    Event Type
    Injury
    Date Received
    January 19, 2022
    Date of Event
    September 12, 2016
    Report Date
    January 19, 2022
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    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: 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.

    Description of Event or Problem · 0

    CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE, DECREASED RANGE OF MOTION : ADHESIONS EVENT IS NOT SERIOUS AND IS CONSIDERED MILD 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) 2016, (LEFT KNEE). TREATMENT: LEFT KNEE MANIPULATION UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052536 SIG PS150 FEM COMP SZ 4N L SIGMA KNEE PRIMARY : KNEE FEMORAL JWH DEPUY IRELAND - 9616671 FP1BN4

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention DEPUY CMW 2G 40G| DEPUY DUOFIX MBT TRAY SZ 3| PFC SIG RPF INS SZ 4 10MM| PFC*SIGMA/OV DOME PAT 3 PEG,32| SIG PS150 FEM COMP SZ 4N L