BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

    MDR report key: 20430315 · Received October 11, 2024

    Report

    Report Number
    3010667733-2024-00744
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    September 17, 2024
    Report Date
    February 7, 2025
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    UDI-DI
    00889797057141
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE, PART #PROPINF, IS COMMERCIALLY AVAILABLE CLEARED 510K K131283. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    CORRECTED FIELD: PRODUCT AVAILABLE TO STRYKER (D9). THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. EVALUATION OF THE EVENT WAS PERFORMED BY THE PROPHECY ENGINEERS RESPONSIBLE FOR SEGMENTATION. ACCORDING TO THEIR REVIEW, THE ENGINEERING DRAWINGS AND QUALITY DOCUMENTS WERE PROCESSED WITHIN NORMAL, ACCEPTABLE RANGES. NO ABNORMALITIES IN THE INTERNAL PROCESS WERE FOUND. AFTER THE INVESTIGATION, AN OSTEOPHYTE WAS IDENTIFIED ANTERIORLY LOCATED BETWEEN THE TIBIA AND TALUS BONES. DUE TO LIMITATIONS OF THE PATIENT¿S CT SCAN AND A BONE-ON-BONE CONTACT IN THIS PARTICULAR AREA, IT IS DIFFICULT TO DETERMINE IF THIS OSTEOPHYTE WAS MORE ATTACHED TO ONE OF THE BONES THAN THE OTHER. AFTER THE SEGMENTATION REVIEW STEP, THE OSTEOPHYTE WAS MODELED AS PART OF THE TIBIA BONE. HOWEVER, IT IS IMPORTANT TO CLARIFY THAT THE MODELS WERE SEGMENTED BY FOLLOWING THE PROPHECY PROTOCOL IN AN APPROPRIATE MANNER. THERE ARE A FEW CT-SCAN SLICES THAT MAY POTENTIALLY CONFUSE THE SPECIALIST IN CHARGE SINCE THE OSTEOPHYTE IS VERY CLOSE TO BOTH BONES. NEVERTHELESS, THE ISSUE FOUND IS ATTRIBUTABLE TO THE DIFFICULT MORPHOLOGY IN THIS AREA AS WELL AS THE CT-SCAN LIMITATIONS AND CASE CHARACTERISTICS. AN ANTERIOR OSTEOPHYTE WAS IDENTIFIED AND SEGMENTED AS ATTACHED TO THE TIBIA. DUE TO THE CHALLENGES OF THIS CASE, AND AFTER THE INVESTIGATION, IT IS DIFFICULT TO DETERMINE THE LEVEL OF ATTACHMENT OR LOOSENESS THIS BODY HAD ON THE TIBIA-TALUS JOINT. THE PROPHECY MODEL'S SEGMENTATION WAS PERFORMED CORRECTLY, AND NO MISSING INFORMATION WAS IDENTIFIED IN THE PROCESS. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED: "THIS MORNING, DOCTOR OPERATED THE PATIENT (CASE (B)(6)) WITH AN INFINITY PROPHECY. THE OPERATION WAS VERY DIFFICULT BECAUSE THE OSTEOPHYTES DID NOT CORRESPOND TO THE PROPHECY GUIDE ON THE TIBIA AND TALUS. HE HAD TO RECUT THE BONE BY HAND AND SPEND A LOT OF EXTRA TIME.". INFORMATION FROM DOCTOR: "I CAN CONFIRM THAT I HAD A GREAT DEAL OF DIFFICULTY THIS MORNING WITH THE FILE N° (B)(6). THE PSI GUIDES POSITIONING WAS VERY DIFFICULT BECAUSE THE MORPHOLOGY OF THE PATIENT'S OSTEOPHYTES DID NOT CORRESPOND TO THOSE OF THE TIBIAL AND TALAR PHANTOM PROVIDED. I HAD TO RECUT THE TIBIA BECAUSE THE CUT WAS INSUFFICIENT AND WITH AN ANTERIOR SLOPE, BY REPOSITIONING THE PSI GUIDE, RELYING SOLELY ON THE 2 ARMS AND MORE PROXIMALLY. ON THE TALUS, I HAD TO USE A SAW TO REMOVE SOME OSTEOPHYTES THAT WERE NOT VISIBLE ON THE TALAR PHANTOM PROVIDED. OVERALL, I'M A LITTLE DISAPPOINTED WITH THE ADJUSTMENT OF THE 2 MEDIAL AND LATERAL ARMS (15MM HIGH) WITH THE PATIENT'S TIBIAL BONE, ALTHOUGH THIS IS EXPECTED TO PROVIDE A PERFECT FIT PROXIMALLY (DUE TO THE TRUNCATED CONE EFFECT).".

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED: "THIS MORNING, DOCTOR OPERATED THE PATIENT (CASE (B)(4)) WITH AN INFINITY PROPHECY. THE OPERATION WAS VERY DIFFICULT BECAUSE THE OSTEOPHYTES DID NOT CORRESPOND TO THE PROPHECY GUIDE ON THE TIBIA AND TALUS. HE HAD TO RECUT THE BONE BY HAND AND SPEND A LOT OF EXTRA TIME." INFORMATION FROM DOCTOR: "I CAN CONFIRM THAT I HAD A GREAT DEAL OF DIFFICULTY THIS MORNING WITH THE FILE N° (B)(4). THE PSI GUIDES POSITIONING WAS VERY DIFFICULT BECAUSE THE MORPHOLOGY OF THE PATIENT'S OSTEOPHYTES DID NOT CORRESPOND TO THOSE OF THE TIBIAL AND TALAR PHANTOM PROVIDED. I HAD TO RECUT THE TIBIA BECAUSE THE CUT WAS INSUFFICIENT AND WITH AN ANTERIOR SLOPE, BY REPOSITIONING THE PSI GUIDE, RELYING SOLELY ON THE 2 ARMS AND MORE PROXIMALLY. ON THE TALUS, I HAD TO USE A SAW TO REMOVE SOME OSTEOPHYTES THAT WERE NOT VISIBLE ON THE TALAR PHANTOM PROVIDED. OVERALL, I'M A LITTLE DISAPPOINTED WITH THE ADJUSTMENT OF THE 2 MEDIAL AND LATERAL ARMS (15MM HIGH) WITH THE PATIENT'S TIBIAL BONE, ALTHOUGH THIS IS EXPECTED TO PROVIDE A PERFECT FIT PROXIMALLY (DUE TO THE TRUNCATED CONE EFFECT)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300473 PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC 1797134 00889797057141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention