BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM

    MDR report key: 19938813 · Received August 8, 2024

    Report

    Report Number
    1038671-2024-02742
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    January 1, 2018
    Report Date
    December 4, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001764
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: (B)(6), 200-02-35 - THREE PEG PATELLA 35MM. (B)(6), 02-010-01-0325 - LOGIC FEMORAL PS CEM RIGHT SZ 2.5. (B)(6), 02-012-45-2515 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 1.5T. (B)(6), 201-78-88 - 4"" DRILL BIT, MOD. HEX 2-PK. (B)(6), 201-78-88 - 4"" DRILL BIT, MOD. HEX 2-PK. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0021-022; 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, LOSS OF RANGE OF MOTION 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, 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 (MDL NO. 3044) (NGG) (MMH). PATIENT ID: IRIS SHOOTS RK 1ST REV. REFER TO (B)(4) RK 2ND REV. 8. PLAINTIFF WAS IMPLANTED WITH THE FOLLOWING EXACTECH DEVICE: KNEE. 9. LEG IN WHICH THE EXACTECH DEVICE WAS IMPLANTED: RIGHT. 10. DATE THE EXACTECH DEVICE WAS IMPLANTED: (B)(6) 2016. 11. STATE IN WHICH THE EXACTECH DEVICE WAS IMPLANTED: (B)(6). 12. DATE THE EXACTECH DEVICE WAS SURGICALLY REMOVED/REVISED: 2018. 13. ON (B)(6) 2016, PLAINTIFF UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY IN WHICH AN EXACTECH OPTETREK LOGIC DEVICE WAS IMPLANTED. IN 2018, PLAINTIFF UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY REVISION. PLAINTIFF SUFFERED FROM PAIN, SWELLING, AND DECREASED RANGE OF MOTION. THE IMPLANTATION OF THE EXACTECH DEVICE AND SUBSEQUENT REVISIONS HAVE CAUSED PERSONAL INJURIES, SEVERE PAIN AND SUFFERING, MENTAL ANGUISH, EMOTIONAL DISTRESS, FEAR, LOSS OF ENJOYMENT OF LIFE, MEDICAL EXPENSES, AND FINANCIAL LOSSES, AND SHE WILL SUSTAIN FUTURE DAMAGES INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE, REHABILITATION, MENTAL AND EMOTIONAL DISTRESS, AND PAIN AND SUFFERING. ACCORDINGLY, PLAINTIFF IS SEEKING COMPENSATORY AND SPECIAL DAMAGES, INCLUDING ATTORNEYS' FEES AND COSTS, AND ALL OTHER AVAILABLE REMEDIES UNDER THE LAW. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), AND PENDING IN THE EASTERN DISTRICT OF (B)(6). PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE. SERIAL NUMBER, ITEM NUMBER AND FULL DESCRIPTION: (B)(6), 02-012-35-2509 - LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM. SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510(K): K093360. CONCOMITANTS; (B)(6), 200-02-35 - THREE PEG PATELLA 35MM. (B)(6), 02-010-01-0325 - LOGIC FEMORAL PS CEM RIGHT SZ 2.5. (B)(6), 02-012-45-2515 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 1.5T. (B)(6), 201-78-88 - 4" DRILL BIT, MOD. HEX 2-PK. (B)(6), 201-78-88 - 4" DRILL BIT, MOD. HEX 2-PK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396245 LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862001764

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11