BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEE - IMPLANT

    MDR report key: 20786229 · Received November 26, 2024

    Report

    Report Number
    1038671-2024-04520
    Event Type
    Injury
    Date Received
    November 26, 2024
    Date of Event
    November 19, 2015
    Report Date
    December 26, 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

    D10: CONCOMITANT DEVICES: (B)(6), 208-10-15 - CC FEMORAL AUG SCREW 15MM; (B)(6), 02-012-45-4030 - LGC TIBIAL FIT TRAY CEM SZ 4F / 3T; (B)(6), 208-05-04 - CC DISTAL FEM AUGMENT SZ 4, 5MM; (B)(6), 208-05-04 - CC DISTAL FEM AUGMENT SZ 4, 5MM; (B)(6), 02-012-50-3014 - TRU TIB AUG 1/2 RL SZ 3, 10MM; (B)(6), 02-010-06-0541 - TRU POST. AUG. SIZE 4, 5MM; (B)(6), 02-010-06-0541 - TRU POST. AUG. SIZE 4, 5MM; (B)(6), 02-010-06-0542 - TRU POST. AUG. SIZE 4, 10MM; (B)(6), 02-012-60-1480 - TRU STEM EXT 14MM X 80MM; (B)(6), 02-012-60-1612 - TRU STEM EXT 16MM X 120MM; (B)(6). THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0021-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D1. D4- CATALOG NUMBER, SERIAL NUMBER, UDI AND EXPIRATION DATE UNKNOWN. G4- 510K UNKNOWN DUE TO SPECIFIC DEVICE NOT BEING REPORTED. H4- MANUFACTURE DATE UNKNOWN. H6. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF MANUFACTURING, USER, AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, RELEVANT CLINICAL INFORMATION, AND PRODUCT INFORMATION WERE NOT PROVIDED. 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

    IT WAS REPORTED THAT APPROXIMATELY UNKNOWN MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844019 KNEE - IMPLANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

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