BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20385737 · Received October 7, 2024

    Report

    Report Number
    1038671-2024-03837
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    May 18, 2022
    Report Date
    October 7, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    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. 3044) (NGG) (MMH) PATIENT ID: TODD SCHULTZ LK REV. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 10 YEAR AND 3 MONTHS AFTER INITIAL IMPLANT. THERE IS NO DEVICE INFORMATION PROVIDED. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE. PATIENT HAS EXPERIENCED DAILY PAIN AND DISCOMFORT IN HIS LEFT KNEE WHICH HAS LIMITED HIS ACTIVITIES OF DAILY LIVING AND IMPACTED HIS QUALITY OF LIFE. PATIENT HAS SUFFERED DEBILITATING INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, PAIN AND DISCOMFORT; SWELLING; GAIT IMPAIRMENT; POOR BALANCE; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; BONE DAMAGE. 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 NEW YORK. 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. INITIAL EBI 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
    247763 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H