BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRU CC TIB INSERT SIZE 5, 15MM

    MDR report key: 21453811 · Received February 24, 2025

    Report

    Report Number
    1038671-2025-01172
    Event Type
    Injury
    Date Received
    February 24, 2025
    Report Date
    April 17, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862613592
    PMA / PMN Number
    K150890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: (B)(6), 02-010-06-0350 - TRU CC FEMORAL SIZE 5 RIGHT, (B)(6), 02-010-06-0551 - TRU POST. AUG. SIZE 5, 5MM, (B)(6), 02-010-06-0551 - TRU POST. AUG. SIZE 5, 5MM, (B)(6), 02-010-06-0552 - TRU POST. AUG. SIZE 5, 10MM, (B)(6), 204-34-16 - STEM EXTENSION W/SLOT 160L X14 MM, (B)(6), 208-10-15 - CC FEMORAL AUG SCREW 15MM. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0021-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. CORRECTED H6 HEALTH EFFECT CLINICAL CODE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. B3: DATE OF EVENT IS UNKNOWN. D6B: EXPLANT DATE IS UNKNOWN. THE PAIN AND PROSTHESIS WEAR REPORTED CANNOT BE CONFIRMED AS THE DEVISES HAVE NOT BEEN REVISED. THE REASON FOR THE LEGAL FILING MAY HAVE BEEN DUE TO THE INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS COULD NOT BE ASSESSED AS THE DEVICES REMAIN IMPLANTED AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED. 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 IS REPORTED VIA LEGAL NOTIFICATION APPROXIMATELY 24 MONTHS AFTER A RIGHT KNEE REVISION SURGERY, THE PATIENT HAS EXPERIENCED PAIN IN HIS RIGHT KNEE. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022. 02-012-65-5015 - LOGIC CC TIB INSERT SIZE 5, 15MM SERIAL: (B)(6), 510K: K150890, UDI: (B)(4), PRODUCT CODE: JWH, X-RAY: NO, OPERATIVE NOTES: NO. CONCOMITANT DEVICES:

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404400 TRU CC TIB INSERT SIZE 5, 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862613592

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other