BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20278887 · Received September 23, 2024

    Report

    Report Number
    1038671-2024-03651
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    June 18, 2019
    Report Date
    October 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: ADDED THE FOLLOWING: HEALTH EFFECT - MEDICAL DEVICE PROBLEM CODE. THE REASON THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE RELATED TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF MANUFACTURING, USER, OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO PRODUCT INFORMATION, IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 0

    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

    LEGAL CASE ¿ USA (MDL NO. (B)(4) (NGG) (MMH) PATIENT ID: (B)(6). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019, WITH UNREVISED SCHEDULED REVISION DATE ON (B)(6) 2024. THERE IS NO DEVICE INFORMATION PROVIDED. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTI DISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. (B)(4) (NGG) (MMH), AND PENDING IN (B)(6) . PER THE TRANSFER ORDER CREATING THIS MULTI DISTRICT 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. INITIAL EBI SURGERY UNABLE TO BE FOUND. AS DIRECTED BY QA MANAGEMENT: THIS LEGAL COMPLAINT CASE IS FROM THE UNITED STATES. THE EVENT DID NOT OCCUR IN, NOR IS IT REPORTABLE FOR BRAZIL, CANADA, EEA/EU, JAPAN, TAIWAN, OR GREAT BRITAIN, EXCLUDING NORTHERN IRELAND. THEREFORE, ONLY THE US REPORTABILITY DETERMINATION WILL BE ASSESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487709 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK.