BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED PATELLA 35MM 3 PEG IMPLANT

    MDR report key: 19724431 · Received July 11, 2024

    Report

    Report Number
    1038671-2024-02360
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    January 16, 2024
    Report Date
    March 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314291
    PMA / PMN Number
    K160484
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES 4906188 - 02-022-35-5011 - TRULIANT TIB IMP PS INSERT SZ 5 11MM 4876544 - 02-020-11-0350 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 5 4894512 - 02-022-45-5040 - TRULIANT TIB FIT TRAY CEM SZ 5F / 4T 4961600 - 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK 4558913 - 201-78-18 - HOLDING PIN HEADLESS NO RIBS W/30 DEG PT 4 PACK 4976625 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK 4915628 - 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL 1038671-04/18/2024-002-R; 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED MAY BE THE RESULT OF FEMORAL LOOSENING AND PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. FAILURE OF THE CEMENT USED TO SECURE THE FEMORAL COMPONENT TO THE BONE, MAY HAVE LEAD TO LOOSENING AT THE CEMENT-IMPLANT INTERFACE; HOWEVER, THIS CANNOT BE CONFIRMED. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 77 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS EFFUSIONS, PAIN, AND LOOSENING. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2386229 ADVANCED PATELLA 35MM 3 PEG IMPLANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862314291

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention| H SEE H10.