BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA C/R NPOR FEM RT SZ 3

    MDR report key: 9079354 · Received September 17, 2019

    Report

    Report Number
    1818910-2019-105067
    Event Type
    Injury
    Date Received
    September 17, 2019
    Date of Event
    August 23, 2019
    Report Date
    August 28, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295232025
    PMA / PMN Number
    K943462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). THIS PRODUCT WAS REPORTED IN ERROR. NO PATIENT DEATH, SERIOUS INJURY OR EVIDENCE OF REPORTABLE PRODUCT MALFUNCTION OCCURRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED. ADDITIONAL INFORMATION RECEIVED ON 16-SEP-2019 INDICATES THE PATIENT WILL HAVE A REVISION IN THE FUTURE. NO MEDICAL OR SURGICAL INTERVENTION AT THIS TIME.

    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). DOTS. CLINICAL NOTIFICATION RECEIVED FOR RIGHT TOTAL KNEE REVISION TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF EVENT: (B)(6) 2019. (RIGHT KNEE). PRODUCTS PRESENT AT THE TIME OF THE REVISION: CATALOG: 960013. LOT: D18021680. DESCRIPTION: SIGMA FEM C/RET CEMENTED RT SZ 3. CATALOG: 129433130. LOT: 8747215. DESCRIPTION: MBT CEMENTED KEEL SZ 3. CATALOG: 196192034. LOT: 8201096. DESCRIPTION: AOX CVD RP TIBIAL INSERT SZ 3 17.5MM. CATALOG: 960102. LOT: 8686623. DESCRIPTION: OVAL DOME PATELLA 3 PEG SZ 38. CATALOG: 3332040. LOT: 8388188. DESCRIPTION: SMART SET BONE CEMENT CMW3. CATALOG: 3332040. LOT: 8388188. DESCRIPTION: SMART SET BONE CEMENT CMW3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868867 PFC*SIGMA C/R NPOR FEM RT SZ 3 SIGMA KNEE PRIMARY : KNEE FEMORAL JWH DEPUY ORTHOPAEDICS INC US D18021680 10603295232025

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention