BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TC3 RP TIBIAL INSERT S2.5,22.5

    MDR report key: 9082389 · Received September 18, 2019

    Report

    Report Number
    1818910-2019-105224
    Event Type
    Injury
    Date Received
    September 18, 2019
    Date of Event
    July 16, 2019
    Report Date
    July 24, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    NJL
    UDI-DI
    10603295242178
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THE REPORTED EVENT WAS NOT RETURNED TO THE INVESTIGATION SITE FOR EVALUATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    SUBJECT ID: (B)(6). DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR SCAR TISSUE LIMITING FLEXION: ADHESIONS; PATELLAR CLUNK; INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT THERE IS A REMOTE POSSIBILITY IT IS RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017. DATE OF EVENT: (B)(6) 2019. DATE OF REVISION: (B)(6) 2019. (RIGHT KNEE). PRODUCTS PRESENT AT THE TIME OF THE AE: CATALOG: 962336. LOT: H42734. DESCRIPTION: SIGMA TIBIAL INSERT TCIII RP CVD SZ 2.5 22.5MM. CATALOG: 960848. LOT: H44566. DESCRIPTION: SIGMA WDG POSTERIOR 8MM SZ 2.5. CATALOG: 960841. LOT: EG1AF4. DESCRIPTION: SIGMA WDG DISTAL 4MM SZ 2.5 RT. CATALOG: 960841. LOT: 143934. DESCRIPTION: SIGMA WDG DISTAL 4MM SZ 2.5 RT. CATALOG: 960092. LOT: H48846. DESCRIPTION: SIGMA FEM TCIII CEMENTED RT SZ 2.5. CATALOG: 129453215. LOT: 745018. DESCRIPTION: UNIVERSAL SLEEVE DISTALLY POROCOAT SZ 31MM. CATALOG: 129435315. LOT: C72656. DESCRIPTION: MBT REVISION TIBIAL TRAY. CATALOG: 129454000. LOT: H31933. DESCRIPTION: MBT REVISION TIBIAL SLEEVE 29MM. CATALOG: 960781. LOT: H69611. DESCRIPTION: SIGMA FEMORAL ADAPTER 5 DEGREE. CATALOG: 960784. LOT: H53353. DESCRIPTION: SIGMA FEMORAL ADAPTER BOLT NEUTRAL. CATALOG: 960848. LOT: 594422. DESCRIPTION: SIGMA WDG POSTERIOR 8MM SZ 2.5. CATALOG: 960101. LOT: 8516857. DESCRIPTION: SIGMA PATELLA OVAL DOME 3 PEGGED 35MM. CATALOG: 3332040. LOT: 8432633. DESCRIPTION: SMART SET BONE CEMENT CMW3. CATALOG: 3332040. LOT: 8432633. DESCRIPTION: SMART SET BONE CEMENT CMW3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878349 TC3 RP TIBIAL INSERT S2.5,22.5 SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT NJL DEPUY ORTHOPAEDICS, INC. 1818910 H42734 10603295242178

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention