BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

    MDR report key: 20403145 · Received October 8, 2024

    Report

    Report Number
    3010667733-2024-00690
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    September 10, 2024
    Report Date
    December 23, 2024
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE COMPLAINT COULDN'T BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WAS PROVIDED. THE PROPHECY TEAM REVIEWED THE RECEIVED INFORMATION AND NOTED: METHODOLOGY: AN INDEPENDENT REVIEWER, A TECHNICIAN TRAINED ON THE PROCEDURE, EVALUATED THE CT SCAN FOR ANATOMICAL ABNORMALITIES AND PROPER COMPLETION OF THE PROCEDURE, PAYING SPECIAL ATTENTION TO THE TIBIA AND TALUS BONE MODELS. AN INDEPENDENT REVIEWER, AN ENGINEER TRAINED ON THE PROCEDURE, COMPLETED A REVIEW OF THE CASE¿S ALIGNMENT, SIZING,GUIDE DESIGN AND REPORT, PAYING SPECIAL ATTENTION TO THE GUIDE DESIGN. AN INDEPENDENT REVIEWER, AN ENGINEER, COMPLETED A REVIEW OF THE CASE¿S ENGINEERING DRAWINGS AND MANUFACTURING FILES FOR PROPER COMPLETION OF THE PROCEDURES. CONCLUSIONS: THE CT SCAN WAS PROCESSED WITHIN NORMAL, ACCEPTABLE RANGES. NO ERRORS WERE IDENTIFIED DURING THE SEGMENTATION PROCEDURE. THE ALIGNMENT GUIDES WERE DESIGNED WITHIN NORMAL, ACCEPTABLE RANGES. NO ABNORMALITIES IN THE INTERNAL PROCESS WERE FOUND. THE ENGINEERING DRAWINGS AND QUALITY DOCUMENTS WERE PROCESSED WITHIN NORMAL, ACCEPTABLE RANGES. NO ABNORMALITIES IN THE INTERNAL PROCESS WERE FOUND. FROM THE PROPHECY OPERATIONS PERSPECTIVE, ALL PROCEDURES WERE FOLLOWED UP ACCORDINGLY AND THE IMPLANT SIZING WAS CHOSEN BASED UPON THE PATIENT¿S ANATOMY CLUES AS USUAL. NO ERRORS WERE IDENTIFIED THAT SUGGEST AN INCORRECT SELECTION OF SIZES WAS PERFORMED. ROOT CAUSE IDENTIFIED: IT WAS NOT POSSIBLE TO IDENTIFY WHAT CAUSED THE INTRAOPERATIVE SIZING ISSUE MENTIONED IN THE COMPLAINT¿S EMAIL. 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.

    Additional Manufacturer Narrative · 0

    CORRECTED FIELD: H6 - DEVICE CODE GRID.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED: "DOCTOR HAD HIS FIRST PROPHECY PROCEDURE (CASE (B)(4)) AND WE COVERED THE OPERATION IN THE UNIVERSITY OF (B)(6). THE SURGICAL GUIDES WERE -AS PLANNED- DELIVERED FOR THE INFINITY SIZES 3 (TIBAL) AND 2 (TALAR). WE HAVE HAD NO PROBLEMS FINDING THE RIGHT POSITIONS RATHER SAVE AND FAST. DURING THE PROCEDURE, AFTER RESECTION OF THE TIBIA AND THE TALUS, WE FOUND THAT THE TRIAL TIBIA AS WELL AS THE TRIAL TALUS IMPLANT WERE FAR TO BIG, ESPECIALLY THE TALAR IMPLANT WAS PROTRUDING FAR ON THE LATERAL SIDE OVER THE TALUS SURFACE IN AP VIEW. THEY DECIDED TO SIZE DOWN TO SIZE 2 TIBIAL AND 1 TALAR AND BESIDES THE FACT THAT WE HAD A SMALL GAP MEDIAL TO THE TIBIAL IMPLANT (THAT COULD BE FILLED UP WITH THE RESECTATE) THE RESULT WAS VERY GOOD. ITS SHOWING THE RESULT WITH ALL IMPLANTS ONE SIZE SMALLER THAN PLANNED EACH BUT NOT YET FILLED UP THE BONE GAP. UNFORTUNATE WE HAVE NOT MADE A PICTURE OF THE X-RAY WITH THE RECOMMENDED SIZES, BUT IT WAS MORE THAN OBVIOUS."

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED: "DOCTOR HAD HIS FIRST PROPHECY PROCEDURE (CASE (B)(4) AND WE COVERED THE OPERATION IN THE UNIVERSITY OF KIEL. THE SURGICAL GUIDES WERE -AS PLANNED- DELIVERED FOR THE INFINITY SIZES 3 (TIBAL) AND 2 (TALAR). WE HAVE HAD NO PROBLEMS FINDING THE RIGHT POSITIONS RATHER SAVE AND FAST. DURING THE PROCEDURE, AFTER RESECTION OF THE TIBIA AND THE TALUS, WE FOUND THAT THE TRIAL TIBIA AS WELL AS THE TRIAL TALUS IMPLANT WERE FAR TO BIG, ESPECIALLY THE TALAR IMPLANT WAS PROTRUDING FAR ON THE LATERAL SIDE OVER THE TALUS SURFACE IN AP VIEW. THEY DECIDED TO SIZE DOWN TO SIZE 2 TIBIAL AND 1 TALAR AND BESIDES THE FACT THAT WE HAD A SMALL GAP MEDIAL TO THE TIBIAL IMPLANT (THAT COULD BE FILLED UP WITH THE RESECTATE) THE RESULT WAS VERY GOOD. ITS SHOWING THE RESULT WITH ALL IMPLANTS ONE SIZE SMALLER THAN PLANNED EACH BUT NOT YET FILLED UP THE BONE GAP. UNFORTUNATE WE HAVE NOT TAKEN A PICTURE OF THE X-RAY WITH THE RECOMMENDED SIZES, BUT IT WAS MORE THAN OBVIOUS.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20201 PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC 1795676

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention