BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM

    MDR report key: 20137515 · Received September 4, 2024

    Report

    Report Number
    1038671-2024-03278
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    October 25, 2023
    Report Date
    November 1, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174536
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, IMPACT CODE, MEDICAL DEVICE CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. THE REASON THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FEMORAL LOOSENING, TIBIAL LOOSENING AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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 AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANTS 3760473 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T 4083444 02-010-03-0340 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4 4092418 200-02-32 - THREE PEG PATELLA 32MM. 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 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

    G6: CORRECTED THE FOLLOWING: TYPE OF INVESTIGATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FEMORAL LOOSENING, TIBIAL LOOSENING AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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 AND RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    LEGAL CASE-USA PATIENT ID: (B)(6). THIS PATIENT HAS A VERIFIED RIGHT KNEE REPLACEMENT ON THE MASTER LIST WITH DR. (B)(6) AT (B)(6). NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. OPERATIVE REPORT FROM REVISION SURGERY ATTACHED. NO FURTHER INFORMATION. SERIAL NUMBER ITEM NUMBER AND FULL DESCRIPTION (B)(6) 02-012-49-4013 - LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM ***SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510(K): K111400. CONCOMITANTS: (B)(6) 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T (B)(6) 02-010-03-0340 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4 (B)(6) 200-02-32 - THREE PEG PATELLA 32MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699200 LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862174536

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Hospitalization| R SEE H11.