BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA FEM ADAPTER 5 DEGREE

    MDR report key: 13043671 · Received December 20, 2021

    Report

    Report Number
    1818910-2021-28444
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    December 7, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295233916
    PMA / PMN Number
    K060515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 · 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION TKA AFTER AN INFECTION WITH A TC3 IMPLANTS PLACED ON (B)(6) 2020. SHE WAS RETURNED TO SURGERY TODAY DUE TO A REPEAT KNEE INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. ADDITIONAL PART USED AND REMOVED, NOT RETURNED 960784/J38U33 960861/HK5168 962343/HU0956. DOI: (B)(6) 2020 - DOR: (B)(6) 2021 (RIGHT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945258 SIGMA FEM ADAPTER 5 DEGREE SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY JWH DEPUY ORTHOPAEDICS INC US 96-0781 J63W04 10603295233916

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention MBT REVISION CEM TIB TRAY S2.5| MBT TRAY SLEEVE POR M/L 37MM| PFC*SIGMA DIS AUG 4MM,SZ3,RGHT| PFC*SIGMA TC3 FEM RT SZ3| PFC*SIGMA/OV/DOME PAT 3PEG,35| SIG FEM ADAP +2/-2 OFFSET BOLT| TC3 RP TIBIAL INSERT S3,15.0| UNIVERSAL FEM SLV FUL POR 34MM| UNIVERSAL STEM 75X12MM FLUTED| UNIVERSAL STEM 75X16MM FLUTED