BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR TIBIAL INSERT SZ4, 9MM

    MDR report key: 16989111 · Received May 23, 2023

    Report

    Report Number
    1038671-2023-01098
    Event Type
    Injury
    Date Received
    May 23, 2023
    Date of Event
    November 1, 2014
    Report Date
    April 8, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862040299
    PMA / PMN Number
    K932776
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D10: CONCOMITTANTS: 200-04-45 - BANDEJA TIB CEMENTADA ALETA 4F/5T 1863149. 232-03-04 - COMP. FEMORAL ASIMETRICO POROSO CR Nº4 DCHA 1720579. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1, B2, D1, H6 - INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION, H7 AND H11 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; HOWEVER, MAY HAVE RESULTED FROM THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, AND/OR MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, WHICH LED TO PROSTHESIS WEAR. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. 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

    H3: THE REVISION REPORTED MAY HAVE BEEN DUE TO THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, AND/OR MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, WHICH LED TO PROSTHESIS WEAR. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AND IMAGES OF THE EXPLANTED DEVICE/RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN INPERSON SITE VISIT WITH UBARMIN HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. THIS PATIENT ((B)(6)) WAS IMPLANTED WITH A 200-24-09-INSERTO TIBIAL CR 4, 9MM, SERIAL NUMBER (B)(6) ON (B)(6)2011. THE INSERT WAS MANUFACTURED ON 2/2/2010 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 2/2/2010 AND WAS 1.5 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON 11/1/2014, APPROXIMATELY 3.0 YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438378 CR TIBIAL INSERT SZ4, 9MM SEE H10 JWH EXACTECH, INC. CR TIBIAL INSERT SZ4, 9MM UNK 10885862040299

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H10.