PROPHECY INFINITY PROPINFRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889797057134), received between Mar 31, 2023 and Dec 17, 2024 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2024Use of Device Problem; Use of Device Problem

  AS REPORTED: "(B)(4): INFINITY PROPHECY TALUS. THE TALUS PINS ARE CONSISTENTLY HIGH (TOO PROXIMAL) WHEN USING THE PROPHECY GUIDES. THE SURGEON ENDS UP WITH A SMALLER FOOTPRINT THAN EXPECTED FOR THE TALUS IMPLANT, AND THEY'VE FREQUENTLY HAD A TIGHTER FIT THAN EXPECTED DUE TO THE SMALLER FOOTPRINT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20951838 ↗
• InjuryOct 4, 2024Device Damaged Prior to Receipt by User; Inaccurate Information; Device Damaged Prior to Receipt by User; Inaccurate Information

  IT WAS REPORTED THAT A "RIGHT ANKLE PROSTHESIS" WAS ORDERED FOR A PATIENT, ACCOMPANIED BY A DISC LABELED "RIGHT ANKLE." HOWEVER, A LEFT ANKLE PROSTHESIS WAS MISTAKENLY MANUFACTURED AND DELIVERED. DURING THE RIGHT ANKLE SURGERY ON (B)(6) 2023, THE SURGEON ENCOUNTERED ISSUES WITH THE CUTTING JIG, WHICH DID NOT FIT PROPERLY. UPON REVIEWING THE PREOPERATIVE TEMPLATE, IT WAS DISCOVERED THAT IT HAD BEEN BASED ON A LEFT ANKLE CT SCAN. ALTHOUGH THE CT SCAN HAD BEEN ORDERED, LABELED, AND READ AS A RIGHT ANKLE SCAN, THE IMAGES WERE ACTUALLY OF THE LEFT ANKLE. THE PROCEDURE WAS ABORTED DUE TO THE LACK OF APPROPRIATE INSTRUMENTATION.

  Patient problems: Insufficient Information

  MAUDE report 20375698 ↗
• MalfunctionJul 10, 2024Material Discolored; Material Discolored

  IT WAS REPORTED THAT BOTH SETS OF PROPHECY GUIDES ARRIVED TO THE ACCOUNT IN PRISTINE CONDITION. AFTER WASH AND STERILIZATION, THERE APPEARED TO BE SPOTS OF DISCOLORATION ON THE GUIDES. UNFORTUNATELY, BOTH CASES HAD TO BE CANCELLED. RESCHEDULED DATE FOR SURGERY TBD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19713241 ↗
• MalfunctionJun 28, 2024Material Discolored; Material Discolored

  IT WAS REPORTED THAT BOTH SETS OF PROPHECY GUIDES ARRIVED TO THE ACCOUNT IN PRISTINE CONDITION. AFTER THE WASH AND STERILIZATION PROCESS, THERE APPEARED TO BE SPOTS OF DISCOLORATION ON THE GUIDES. UNFORTUNATELY, BOTH CASES HAD TO BE CANCELLED. RESCHEDULED DATE FOR SURGERY TBD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633248 ↗
• MalfunctionSep 6, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT PROPHECY GUIDES WERE INCOMPATIBLE WITH PATIENT'S ANATOMY AFTER BEING BUILT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Extraskeletal ossification; Insufficient Information

  MAUDE report 17695102 ↗
• MalfunctionAug 16, 2023Off-Label Use; Device Handling Problem; Off-Label Use; Device Handling Problem

  THIS EVENT IS REPORTABLE DUE TO THE PRODUCT MIX IN THE CENTRAL STERILE PROCESSING WHICH RESULTED IN THE WRONG GUIDES BEING USED IN THE PATIENT.

  Patient problems: Insufficient Information; Limb Fracture

  MAUDE report 17561547 ↗
• MalfunctionAug 16, 2023Off-Label Use; Device Handling Problem; Off-Label Use; Device Handling Problem

  THIS EVENT IS REPORTABLE DUE TO THE PRODUCT MIX IN THE CENTRAL STERILE PROCESSING WHICH RESULTED IN THE WRONG GUIDES BEING USED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17556086 ↗
• MalfunctionAug 10, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT A PATIENT EXHIBITED SIGNIFICANT MISALIGNMENT OF TIBIAL BLOCKS FOR UNKNOWN REASONS. THE SCANS WERE CONDUCTED ON (B)(6), 2023, AND SURGERY PERFORMED ON (B)(6), 2023.

  Patient problems: Insufficient Information

  MAUDE report 17497504 ↗
• MalfunctionJun 30, 2023Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE BLOCKS FOR THE CASE WERE MADE FOR A RIGHT ANKLE WHEN THE CASE WAS FOR A LEFT ANKLE. THIS WAS DUE TO THE SCANS THAT WERE UPLOADED WERE FOR THE RIGHT ANKLE AND WERE CONFIRMED VIA EMAIL THAT THE LEG SIDE ON THE SCANS WAS CORRECT. THE SURGERY WAS COMPLETED BY USING THE STANDARD INSTRUMENTATION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240070 ↗
• MalfunctionMar 31, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE TIBIAL BLOCK FOR THIS CASE HAD A RIDGE ON IT THAT PREVENTED THE CUT GUIDE FROM GOING ALL THE WAY DOWN. IT SAT LIKE 5MM HIGHER THAN IT SHOULD HAVE.

  Patient problems: Insufficient Information

  MAUDE report 16660693 ↗