BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 21253121 · Received January 28, 2025

    Report

    Report Number
    1038671-2025-00484
    Event Type
    Injury
    Date Received
    January 28, 2025
    Date of Event
    August 10, 2020
    Report Date
    March 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. D10 CONCOMITANTS: (B)(6), 02-012-44-3015 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM. (B)(6), 02-010-01-0230 - LOGIC FEMORAL PS CEM LEFT SZ 3. (B)(6), 02-012-41-3030 - LOGIC TIBIA TRAPTRAY CEM SZ 3F/3T.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B5 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). PATIENT ID: (B)(6) LK REV 1. RELATED (B)(4) LK REV 2. IT WAS REPORTED 84 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS SIGNIFICANT FLUID IN HIS KNEE. THE FLUID WAS ASPIRATED AND FOUND TO HAVE BACTERIA AND DIAGNOSED WITH ACUTE ON CHRONIC PERIPROSTHETIC LEFT TOTAL KNEE REPLACEMENT INFECTION. PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT AND POLYETHYLENE EXCHANGE. THE PATIENT WAS PLACED ON IV ANTIBIOTICS. IT WAS NOTED THAT THE PATIENT WAS DOING OK AT HIS LAST FOLLOW UP APPOINTMENT APPROXIMATELY 5 MONTHS POST PROCEDURE. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. LEGAL CASE - USA. PATIENT ID: (B)(6) LK REV 1. RELATED CASE FOR LK REV 2 REQUESTED. AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 6 YEARS, 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE IRRIGATION AND DEBRIDEMENT AND POLYETHYLENE EXCHANGE ON (B)(6) 2020. THE PATIENT HAD DONE WELL UNTIL IT WAS NOTED THAT HE HAD SIGNIFICANT FLUID IN HIS KNEE. THIS FLUID WAS ASPIRATED AND WAS FOUND TO HAVE BACTERIA. HE WAS DIAGNOSED WITH ACUTE ON CHRONIC PERIPROSTHETIC LEFT KNEE INFECTION. HE WAS PLACED ON IV ANTIBIOTICS FOLLOWED BY A YEAR-LONG COURSE OF ORAL ANTIBIOTICS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. **THE CAUSE OF THE PATIENT'S INFECTION AND POLY REVISION SURGERY AS RELATED TO THE DEVICES CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. CLINICAL INFORMATION ABOUT THE PATIENT WAS NOT AVAILABLE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. NO X-RAYS OR IMAGES OBTAINED. EBI INITIAL SURGERY RESULTS & QAD SERIAL SEARCH ATTACHED. HISTORICAL RECORDS & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. NO FURTHER INFORMATION. (B)(6) 02-012-44-3015 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT. APPROXIMATELY 9 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2377835 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male SEE H11