BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPHECY INFINITY

    MDR report key: 11585794 · Received March 29, 2021

    Report

    Report Number
    1043534-2021-00046
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    March 3, 2021
    Report Date
    May 5, 2021
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HSN
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # PROPINF, 510K # K131283 WAS CLEARED IN THE UNITED STATES. H6: THE PRODUCTS WERE NOT RETURNED; HOWEVER, IMAGES WERE PROVIDED THAT SHOW THE GUIDES IN SITU DURING THE OPERATION. A POST REVISION RADIOGRAPHIC IMAGE WAS ALSO PROVIDED. EVALUATION OF THE IMAGE DOES FIND INFINITY DEVICES IN VIVO AND A MEDIAL MALLEOLUS PLATE AND SCREWS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT SURGERY. ALLEGEDLY, THE TALAR GUIDE WAS MANUFACTURED INCORRECTLY AND DID NOT MATCH THE CT SCANS. THE REPORT IMAGE OF TALAR NECK WAS DIFFERENT TO THE CT SCAN, SHOWING OSTEOPHYTES AND VOIDS THAT WEREN'T ON THE CT SCAN. THIS RESULTED IN THE PSI GUIDE NOT SITTING FLUSH WITH THE TALUS BONE. MORE BONE WAS TAKEN FROM THE TIBIA, RESULTING IN THE SURGEON HAVING TO PLACE A MEDIAL MALLEOLUS PLATE ON THE TIBIA AS A PREVENTATIVE FOR POTENTIAL FRACTURE.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG #: PROPINF, 510K #: K131283 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT SURGERY. ALLEGEDLY, THE TALAR GUIDE WAS MANUFACTURED INCORRECTLY AND DID NOT MATCH THE CT SCANS. THE REPORT IMAGE OF TALAR NECK WAS DIFFERENT TO THE CT SCAN, SHOWING OSTEOPHYTES AND VOIDS THAT WEREN'T ON THE CT SCAN. THIS RESULTED IN THE PSI GUIDE NOT SITTING FLUSH WITH THE TALUS BONE. MORE BONE WAS TAKEN FROM THE TIBIA, RESULTING IN THE SURGEON HAVING TO PLACE A MEDIAL MALLEOLUS PLATE ON THE TIBIA AS A PREVENTATIVE FOR POTENTIAL FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482385 PROPHECY INFINITY PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY, INC. PROPINFE

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other