BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 9MM

    MDR report key: 19959749 · Received August 12, 2024

    Report

    Report Number
    1038671-2024-02770
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    February 21, 2024
    Report Date
    January 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001801
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND SUSPECTED LOOSENING 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

    LEGAL CASE - USA. PATIENT ID: (B)(6). RELATED CASE: (B)(4). THIS PATIENT IS VERIFIED BILATERAL KNEES ON PRIMARY LEFT KNEE (B)(6) 2011 AND RIGHT KNEE (B)(6) 2013 BOTH AT HOSPITAL OF SPECIAL SURGERY. SHE HAD LEFT KNEE REVISION (B)(6) 2023 WITH DR. (B)(6) (ALREADY APPROVED). SHE HAD RIGHT KNEE REVISION (B)(6) 2024 WITH DR (B)(6) (OP REPORT ATTACHED). PLEASE REVIEW THE ATTACHED REVISION OP REPORT AND CONFIRM THIS IS WITHIN THE SCOPE OF THE RECALL. PREVIOUSLY VERIFIED ON HSS MASTER LIST. CLAIM IS NOW ACCEPTED AS COMPENSABLE. PATIENT NAME: (B)(6). SURGERY 2: (B)(6), (B)(6) 2013, RIGHT KNEE PRIMARY, SERIAL #: (B)(6). NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. UNABLE TO LOCATE EBI INITIAL SURGERY. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. NO FURTHER INFORMATION. (B)(6), 02-012-35-3009, LOGIC TIBIA PS MOD INSRT SZ 3 9MM. SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. UDI: (B)(4). 510K: K033883.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724945 LOGIC TIBIA PS MOD INSRT SZ 3 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862001801

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention| H