BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20406312 · Received October 9, 2024

    Report

    Report Number
    1038671-2024-03889
    Event Type
    Injury
    Date Received
    October 9, 2024
    Date of Event
    March 25, 2021
    Report Date
    October 9, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: - STEM EXTENSION 160L X12 MM (CAT# 204-32-16 / SERIAL# (B)(6) - 3" TROCAR, MOD. HEX 2PK (CAT# 201-78-81 / SERIAL# (B)(6)) - 3" TROCAR, MOD. HEX 2PK (CAT# 201-78-81 / SERIAL# (B)(6)) - TRAPEZOID TIBIAL TRAY SZ 1F/2T, 2F/2T (CAT# 204-04-22 / SERIAL# (B)(6)) - THREE PEG PATELLA 32MM (CAT# 200-02-32 / SERIAL# (B)(6)). THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    LEGAL CASE GERALDINE BILLUPS RK REV3. (B)(4) RK 2 STAGE REV1. (B)(4) RK REV2. IT WAS REPORTED VIA LEGAL BRIEF THAT A PATIENT CONTINUED TO HAVE DIFFICULTY WITH HER RIGHT KNEE AFTER A SECOND REVISION ON (B)(6) 2012, AND, IN (B)(6) 2021, SHE SWITCHED HER CARE TO DIFFERENT HOSPITAL. ON (B)(6) 2021, APPROXIMATELY 8 YEARS 5 MONTHS POST THE SECOND REVISION, THE PATIENT UNDERWENT ANOTHER REVISION DUE TO LOOSENING AND BONE LOSS RELATED TO THE INSERT. AS A RESULT OF THIS REVISION SURGERY, THE PATIENT'S POPLITEAL ARTERY WAS SEVERED, AND THE PATIENT CONTINUES TO SUFFER FROM MEDICAL COMPLICATIONS AND RISKS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. CONCOMITANT PRODUCTS: - STEM EXTENSION 160L X12 MM (CAT# 204-32-16 / SERIAL# (B)(6)) - 3" TROCAR, MOD. HEX 2PK (CAT# 201-78-81 / SERIAL# (B)(6)) - 3" TROCAR, MOD. HEX 2PK (CAT# 201-78-81 / SERIAL# (B)(6)) - TRAPEZOID TIBIAL TRAY SZ 1F/2T, 2F/2T (CAT# 204-04-22 / SERIAL# (B)(6)) - THREE PEG PATELLA 32MM (CAT# 200-02-32 / SERIAL# (B)(6)). 510K: K954208.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54515 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11