BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR TIBIAL INSERT SZ 2, 9MM, SLOPE +

    MDR report key: 19434590 · Received May 31, 2024

    Report

    Report Number
    1038671-2024-01636
    Event Type
    Injury
    Date Received
    May 31, 2024
    Date of Event
    February 6, 2023
    Report Date
    November 22, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: (LEFT AND RIGHT KNEE) AA4472 1510-S - CEMEX SYSTEM FAST 70 GM, AA4681 1510-S - CEMEX SYSTEM FAST 70 GM, 2102174 200-02-32 - THREE PEG PATELLA 32MM, 2222970 200-02-32 - THREE PEG PATELLA 32MM, 2214080 200-04-22 - CEMENTED FINNED TIB. TRA SZ 2F/2T, 2242140 200-04-22 - CEMENTED FINNED TIB. TRA SZ 2F/2T, 2047283 232-03-02 - OPTETRAK ASY, CR POROUS FEMORAL, SZ 2, RIGHT, 2001312 232-02-02 - OPTETRAK ASY, CR POROUS FEMORAL, SZ 2, LEFT, THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0019-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS THE 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 FOLLOWING SECTIONS WERE UPDATED: H6. THE FOLLOWING SECTIONS WERE CORRECTED: H6. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INSTABILITY OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION 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

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 132 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. THE SURGEON OBSERVED A CATASTROPHIC POLYETHYLENE BEARING FAILURE UPON REVISION SURGERY. THE SURGEON ALSO NOTED SIGNIFICANT METALLOSIS AND A LARGE CYST IN THE POSTERIOR LATERAL ASPECT OF THE DISTAL FEMUR. PRIOR TO THE REVISION SURGERY, THE PATIENT SUFFERED FROM PAIN, SWELLING, AND INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215267 CR TIBIAL INSERT SZ 2, 9MM, SLOPE + PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H10.