BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 41MM

    MDR report key: 20724268 · Received November 19, 2024

    Report

    Report Number
    1038671-2024-04426
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    October 16, 2024
    Report Date
    January 23, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039620
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D8 H6 THE FOLLOWING SECTIONS WERE CORRECTED: B2 H6 THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE PATELLA COMPONENT IN THE PACKAGING RECALL. DURING THE PROCEDURE TO ADDRESS THE PATELLA REVISION, THE TIBIAL INSERT MAY HAVE BEEN REMOVED IN ORDER TO PROVIDE BETTER EXPOSURE FOR THE PROCEDURE OR TO UP/DOWNSIZE THE COMPONENT. WEAR OF THE INSERT COULD NOT BE CONFIRMED FROM THE PROVIDED INFORMATION AND THE DEVICE WAS NOT INCLUDED IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANTS: 02-012-38-3011 LOGIC TIBIA PS RBK INSRT SZ 3 11MM 5813372 203-90-22 - (3118) HALL PWR PRO/VERS PWR PLUS 90X19X1.19MM 304830 203-90-01 - 11-2624 POWERPRO SAWBLADE 314534 02-012-43-3040 - LGC TIBIA RBKTRAY CEM SZ 3F/ 4T 5337166 02-010-01-0330 - LGC FEMORAL PS CEM RIGHT SZ 3 6444586.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 4 YEARS AND 5 MONTHS POST INITIAL RIGHT TOTAL KNEE ARTHROPLASTY (TKA), THE PATIENT UNDERWENT REVISION DUE TO RECALL. THE LINER AND PATELLA WERE EXCHANGED. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92675 THREE PEG PATELLA 41MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039620

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention| H SEE H11