BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 32MM

    MDR report key: 19471365 · Received June 5, 2024

    Report

    Report Number
    1038671-2024-01762
    Event Type
    Injury
    Date Received
    June 5, 2024
    Date of Event
    May 19, 2020
    Report Date
    June 24, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039590
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1312822 204-24-11 - PS TIBIAL INSERTS SZ 4, 11MM 1735336 234-03-04 - OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 4, 2955632 200-02-32 - THREE PEG PATELLA 32MM 3003748 204-04-44 - TRAPEZOID TIBIAL TRAY SZ 4F/4T THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT 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.

    Additional Manufacturer Narrative · 0

    H10. MFR#S FOR THIS EVENT- 1038671-2023-00347 REPORT 1 OF 4, 1038671-2024-01761 REPORT 2 OF 4, 1038671-2024-01764 REPORT 4 OF 4. H11. ADDITIONAL MANUFACTURER NARRATIVE- REPORT 3 OF 4. H3. THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF LOOSENING OF THE FEMORAL COMPONENT AND TIBIAL TRAY, WEAR OF THE PATELLA AND TIBIAL INSERT, OSTEOLYSIS, AND JOINT INSTABILITY. THE ASEPTIC (NON-INFECTED) LOOSENING WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANTS AND THE BONES. THE CAUSE AND EXTENT OF THE PATELLAR WEAR CANNOT BE DETERMINED BECAUSE THE REVISED COMPONENTS WERE NOT RETURNED FOR EVALUATION AND NO IMAGES OR RADIOGRAPHS WERE PROVIDED. EXACTECH COMPLAINT HISTORY FROM 01/01/2008 ¿ 04/01/2024 WAS USED TO CALCULATE A COMPLAINT OCCURRENCE RATE FOR EACH ALLEGED FAILURE, RESPECTIVELY, OF <0.5%. THIS IS CONSIDERED ¿VERY LOW¿. THIS EVENT DOES NOT THIS DOES NOT APPEAR TO BE DESIGN-RELATED. A REVIEW OF THE RISK MANAGEMENT REPORT AND RISK ASSESSMENT AND CONTROLS REPORT WAS CONDUCTED TO ENSURE THE RISKS WERE INCLUDED AND THE OCCURRENCES ARE BELOW THE THRESHOLD. H6. 4581 FOR PATELLA TRACKING.THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 73 MONTHS AFTER A TOTAL RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, INSTABILITY, AND OSTEOLYSIS. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295625 THREE PEG PATELLA 32MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039590

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Hospitalization| R