BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 19425620 · Received May 30, 2024

    Report

    Report Number
    1038671-2024-01592
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    March 25, 2024
    Report Date
    November 1, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173478
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    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.

    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.

    Additional Manufacturer Narrative · 0

    1038671-2024-03144 D10 CONCOMITANT DEVICES: (B)(6) 02-010-01-0220 - LOGIC FEMORAL PS CEM LEFT SZ 2. N/A 02-012-41-2010 OR 2020 - LOGIC TIBIA TRAPTRAY CEM SZ 2F/1T OR SZ 2F/2T. N/A 200-02-29 OR 32 - THREE PEG PATELLA 29MM OR 32MM. D4 PN: 02-012-44-2009 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 9MM. SERIAL: (B)(6). UDI: (B)(4). G4 510K: K110547. H4 MANUFACTURING DATE 24NOV2014. H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, TYPE OF INVESTIGATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FEMORAL LOOSENING, AND/OR 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 AND RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 112 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR DESTRUCTION OF BONE, OSSEOUS RESORPTION, OSTEOLYSIS, SYNOVITIS, SWELLING, PAIN, LIMITED RANG EOF MOTION, DIFFICULTY WALKING, AND LOSS OF ENJOYMENT OF LIFE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. RIGHT KNEE ALSO OPERATED IN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100122 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862173478

    Patients

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