BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR TIBIAL INSERT SZ4, 9MM

    MDR report key: 18352784 · Received December 18, 2023

    Report

    Report Number
    1038671-2023-03022
    Event Type
    Injury
    Date Received
    December 18, 2023
    Date of Event
    August 23, 2023
    Report Date
    May 15, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862040299
    PMA / PMN Number
    K933610
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED IS MOST LIKELY THE RESULT OF POLYETHYLENE WEAR AND OSTEOLYSIS OVER THE COURSE OF 12.5 YEARS OF IMPLANTATION. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE REPORTED POLYETHYLENE WEAR AND OSTEOLYSIS CANNOT BE DETERMINED AS THE EXPLANTED DEVICES WERE NOT RETURNED FOR EVALUATION AND RADIOGRAPHS, PHOTOGRAPHS, OR OPERATIVE NOTES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER D10: CONCOMITANTS: 1944298 200-04-44 - CEMENTED TIB TRAY FIN 4F/4T 1741403 232-02-04 - COMP. POROUS ASYMETRIC FEMORAL CR Nº4 IZQ ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: H6- HEALTH EFFECT/CLINICAL CODE, H6- COMPONENT CODE, H6- INVESTIGATION FINDINGS- 140/WEAR PROBLEM, 4243/PACKAGING MATERIALS PROBLEM NO LONGER APPLY, H6-INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1/D2A/D2B, D4, H6. MDR SECTION CODES UPDATED/CORRECTED: C. THE REVISION REPORTED IN IS MOST LIKELY THE RESULT OF POLYETHYLENE WEAR AND OSTEOLYSIS OVER THE COURSE OF 12.5 YEARS OF IMPLANTATION. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE REPORTED POLYETHYLENE WEAR AND OSTEOLYSIS CANNOT BE DETERMINED AS THE EXPLANTED DEVICES WERE NOT RETURNED FOR EVALUATION AND RADIOGRAPHS, PHOTOGRAPHS, OR OPERATIVE NOTES WERE NOT 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

    EMAIL TO COMPLAINTS - SPAIN UBARMIN #92 DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN IN PERSON 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. ON (B)(6) 2023 UPDATES TO THE EXCEL LISTING WERE PROVIDED. THIS PATIENT (B)(6) WAS IMPLANTED WITH A 200-24-09 CR TIBIAL INSERT SZ4, 9MM, SERIAL NUMBER (B)(6) ON (B)(6) 2011. THE INSERT WAS MANUFACTURED ON 4/26/2010 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 4/26/2010 AND WAS 0.89 YEARS OF SHELF AGE AT THE TIME OF IMPLANT. PATIENT WAS REVISED ON (B)(6) 2023 APPROXIMATELY 12.45 YEARS POST IMPLANT. MASSIVE LYSIS OF THE TIBIAL PLATEAU AND INTERNAL FEMORAL CONDYLE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886588 CR TIBIAL INSERT SZ4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. CR TIBIAL INSERT SZ4, 9MM UNK 10885862040299

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention