BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20417940 · Received October 10, 2024

    Report

    Report Number
    1038671-2024-03913
    Event Type
    Injury
    Date Received
    October 10, 2024
    Date of Event
    April 24, 2023
    Report Date
    October 16, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1038671-2023-01326 CORRECTION: PLEASE DISREGARD THIS REPORT AS IT WAS REPORTED IN ERROR. EVENT WAS PREVIOUSLY REPORTED UNDER REPORT #1038671-2023-01326.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: (B)(6), 02-010-03-0230 - LOGIC CR FEMORAL CEM, LEFT, SZ 3; (B)(6), 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T; (B)(6), 200-02-26 - THREE PEG PATELLA 26MM. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 31JAN2024: LEGAL CASE ¿ USA (MDL NO. (B)(4)) (NGG) (MMH). PATIENT ID: (B)(6). CASE NO: (B)(4). 8. PLAINTIFF WAS IMPLANTED WITH THE FOLLOWING EXACTECH DEVICE: KNEE. 9. LEG IN WHICH THE EXACTECH DEVICE WAS IMPLANTED: LEFT. 10. DATE THE EXACTECH DEVICE WAS IMPLANTED: (B)(6) 2018 11. STATE IN WHICH THE EXACTECH DEVICE WAS IMPLANTED: (B)(6). 12. DATE THE EXACTECH DEVICE WAS SURGICALLY REMOVED/REVISED: (B)(6) 2023. 13. PAIN AND SUFFERING FROM PREMATURE REVISION SURGERY, LOSS OF MOBILITY AND ENJOYMENT OF LIFE, MEDICAL EXPENSES AND OTHER FINANCIAL HARDSHIP. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. (B)(4) (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. ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 05JAN2024: LEGAL CASE-USA. PATIENT ID: (B)(6). DOCKET NO: (B)(4). ORIGINAL DESCRIPTION SUMMARY: EXPERIENCE REPORT - USA. PATIENT ID: (B)(6). AS REPORTED, APPROXIMATELY 4.5 YEARS POST OP INITIAL LEFT TKA, THIS PATIENT WAS REVISED DUE TO THE RECALL. SURGEON PERFORMED A POLY SWAP. NO PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PRODUCT NOT RETURNING: HOSPITAL KEPT. INITIAL IMPLANT DATE: (B)(6) 2018. NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. (B)(6), 02-012-47-3009 - LOGIC CR TIB INSERT STD, SZ 3, 9MM. SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. Z-0021-2022. 510K: K111400. CONCOMITANTS: (B)(6), 02-010-03-0230 - LOGIC CR FEMORAL CEM, LEFT, SZ 3; (B)(6), 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T; (B)(6), 200-02-26 - THREE PEG PATELLA 26MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2260480 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

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