BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 15MM

    MDR report key: 19832588 · Received July 25, 2024

    Report

    Report Number
    1038671-2024-02541
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    February 20, 2023
    Report Date
    November 27, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001832
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES: (1937585) 02-012-39-3040 - LOGIC TIBIA FIN TRAY CEM SZ 3F/4T, (2240882)200-02-29 - THREE PEG PATELLA 29MM, (2283013) 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, (2290616) 201-78-81 - 3"" TROCAR, MOD. HEX 2PK, (2291047)02-010-01-0230 - LOGIC FEMORAL PS CEM LEFT SZ 3. 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 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 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 BULK LEGAL EMAIL (440). PATIENT ID: (B)(6). THE PATIENT HAS RETAINED AN ATTORNEY WHO CONTACTED EXACTECH TO TOLL THE STATUTE OF LIMITATIONS AND PRESERVE THE PATIENT¿S ABILITY TO FILE A LAWSUIT IN THE FUTURE. BECAUSE THE PATIENT HAS RETAINED AN ATTORNEY TO PRESERVE THE RIGHT TO FILE A LEGAL ACTION SEEKING REDRESS FOR ALLEGED PAST SERIOUS INJURY OR FUTURE SERIOUS INJURY ALLEGEDLY STEMMING FROM THE USE OF AN EXACTECH DEVICE, THE PATIENT APPEARS TO ALLEGE THAT THERE IS A PURPORTED DEFICIENCY IN THE DEVICE AND/OR THAT THE PATIENT HAS INCURRED SERIOUS INJURY AS A RESULT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244784 LOGIC TIBIA PS MOD INSRT SZ 3 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11.