BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 3, 13MM

    MDR report key: 13172772 · Received January 5, 2022

    Report

    Report Number
    1038671-2022-00008
    Event Type
    Injury
    Date Received
    January 5, 2022
    Date of Event
    May 2, 2016
    Report Date
    July 22, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048325
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: TRAPEZOID TIBIAL TRAY SZ 3F/2T (CAT# 204-04-32 / SERIAL# (B)(4)); TIBIAL AUGMENT BLOCK 1/2-SZ 2 5MM (CAT# 204-62-05 / SERIAL# (B)(4)); STEM EXTENSION 80L X12 MM (CAT# 204-32-08 / SERIAL# (B)(4)); TIBIAL AUGMENT BLOCK 1/2-SZ 2 5MM (CAT# 204-62-05 / SERIAL# (B)(4)); THREE PEG PATELLA 35MM (CAT# 200-02-35 / SERIAL# (B)(4)); TIBIAL STEM EXT. SCREW (CAT# 204-70-00 / SERIAL# (B)(4)). ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    AS REPORTED, APPROXIMATELY SEVEN YEARS POST TKA, PATIENT HAD A PARTIAL TIBIAL REVISION FOR AN UNKNOWN REASON. THIS IS NOT A PE LINER ISSUE DUE TO NON-CONFORMING EVOH BAGS, THERE IS NO INFORMATION RECEIVED ANY INFO OF INCIDENT AT THAT TIME, THERE IS NO COMPLAINT REGISTERED ON OUR SIDE. NO ADDITIONAL INFORMATION AVAILABLE. UPON REVIEW, THERE IS NO ALLEGATION AGAINST THE DEVICE AS THE REASON FOR REVISION WAS NOT REPORTED. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS PATIENT CONDITIONS.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY SEVEN YEARS POST TKA, PATIENT HAD A PARTIAL TIBIAL REVISION FOR AN UNKNOWN REASON. THIS IS NOT A PE LINER ISSUE DUE TO NON-CONFORMING EVOH BAGS, THERE IS NO INFORMATION RECEIVED ANY INFO OF INCIDENT AT THAT TIME, THERE IS NO COMPLAINT REGISTERED ON OUR SIDE. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51828 PS TIBIAL INSERTS SZ 3, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 13MM UNK 10885862048325

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| R