BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED PATELLA 29M 3 PEG IMPLANT

    MDR report key: 19990766 · Received August 15, 2024

    Report

    Report Number
    1038671-2024-02856
    Event Type
    Injury
    Date Received
    August 15, 2024
    Date of Event
    July 17, 2024
    Report Date
    September 16, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 6655097, 02-022-45-3525 - TRULIANT TIB FIT TRAY CEM SZ 3.5F/2.5T.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H11. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. AS A RESULT, THIS COMPLAINT EVENT IS NO LONGER CONSIDERED REPORTABLE BY EXACTECH AND THIS REPORT MAY BE DISREGARDED.

    Description of Event or Problem · 0

    EXPERIENCE REPORT USA. PATIENT ID: (B)(6). IT WAS REPORTED THAT THIS 72 Y/O FEMALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 3 YEARS 2 MONTHS POST OP. PATIENT COMPLAINED OF PAIN. LOOSE FEMUR AND RECALLED POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: CHAIN OF COMMAND. DUE TO RECALL HOSPITAL WILL NOT RELEASE. LEFT SIDE REVISION OF EXACTECH IMPLANTS. INITIAL IMPLANT DATE: (B)(6) 2021. PATIENT WAS NOT REVISED TO EXACTECH DEVICES: DUE TO RECALL SURGEON IS USING COMPETITOR. IS THE REPORTED EVENT RELATED TO THE BREAKAGE OF A DEVICE? NO. DID THE REPORTED EVENT LEAD TO A SURGICAL DELAY/PROLONGATION? NO. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES, X-RAYS & EBI ATTACHED. PRODUCT NOT RETURNING: CHAIN OF COMMAND. DUE TO RECALL HOSPITAL WILL NOT RELEASE. 5831770, 02-022-35-3509 - TRULIANT TIB IMP PS INSERT SZ 3.5 9MM. THE SERIAL NUMBER (B)(6) IS AFFECTED BY THE RECALL. UDI: (B)(4). 510K: K152170. PRO CODE: JWH. 5827796, 02-020-11-0235 - TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5. UDI: (B)(4). 510K: K170240. PRO CODE: JWH. 6749433, 200-07-29 - ADVANCED PATELLA 29M 3 PEG IMPLANT. THE SERIAL NUMBER (B)(6) IS AFFECTED BY THE RECALL. UDI: (B)(4). 510K:K160484. PROD. CODE: JWH. CONCOMITANTS: 6655097, 02-022-45-3525 - TRULIANT TIB FIT TRAY CEM SZ 3.5F/2.5T.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164380 ADVANCED PATELLA 29M 3 PEG IMPLANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention SEE H11.