PROPHECY INBONE PROPINBRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889797057110), received between Jul 18, 2022 and Mar 31, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Positioning Problem

  THE PROPHECY BLOCK FOR STEM ALIGNMENT GUIDE'S K-WIRE HOLES WERE NOT DRILLED ALL THE WAY THROUGH. THE SURGEON HAD TO DRILL THEM OUT BY HAND WHICH CAUSED THE K-WIRES TO SKIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24745398 ↗
• InjuryNov 21, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  DURING A PROPHECY CASE, A SEVERE MISMATCH WAS IDENTIFIED BETWEEN THE PATIENT-SPECIFIC INBONE TRIAL BLOCKS AND THE PATIENT¿S ANATOMY. ALTHOUGH THE BLOCKS, CASE NUMBERS, PATIENT NAME, AND WEBOPS SHIPMENT INFORMATION ALL ALIGNED CORRECTLY, THE BLOCKS DID NOT FIT INTRAOPERATIVELY. A DETAILED REVIEW COMPARING THE PATIENT¿S ORIGINAL CT SCAN FROM THE SCANNING FACILITY TO THE NATIVE CT IN THE SURGEON¿S PACS SYSTEM CONFIRMED THAT BOTH ACCURATELY REPRESENTED THE PATIENT¿S ANATOMY. HOWEVER, THE CT IMAGES DISPLAYED IN THE PROPHECY REPORT REFLECTED ANATOMY INCONSISTENT WITH PATIENT R.F. SUBSEQUENT COMPARISON WITH THE PATIENT¿S X-RAYS FURTHER CONFIRMED THAT THE CT USED TO BUILD THE PROPHECY REPORT DID NOT BELONG TO THIS PATIENT. THIS APPEARS TO BE AN EXTREMELY RARE OCCURRENCE AND RAISES CONCERN THAT ANOTHER MISMATCHED SCAN AND CORRESPONDING BLOCK SET MAY EXIST. VERIFICATION AND TROUBLESHOOTING ARE NEEDED TO CONFIRM THE ISSUE AND PREVENT RECURRENCE.

  Patient problems: Insufficient Information

  MAUDE report 23623814 ↗
• 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 17504144 ↗
• MalfunctionDec 5, 2022Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROPHECY BLOCKS DID NOT FIT PATIENT. THE SURGICAL TEAM WAS 100% SURE IT WAS CORRECT BLOCKS FOR THE PATIENT. THE BLOCKS SAT TO MEDIAL. THE PHYSICIAN HAD TO CUT THE BLOCKS TO MAKE THEM WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915799 ↗
• MalfunctionOct 29, 2022Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A TOTAL ANKLE REPLACEMENT PROCEDURE. DURING THE SURGERY, THE PHYSICIAN HAD AN ISSUE WITH THE PROPHECY BLOCKS. THE BLOCK PIN HOLES DID NOT LINE UP WITH THE SIZE 4 CORRESPONDING RESECTION GUIDE (OR SIZE 3 WHICH WAS TESTED AS WELL). AFTER PINNING THE PROPHECY BLOCK, THE SURGICAL TEAM ATTEMPTED TO PLACE THE RESECTION BLOCK OVER THE WIRES IN THE TIBIAL CUT PROX CORNERS PER THE USUAL TECHNIQUE AND THE PINS WERE OFF BY 3-4 MM. THE PHYSICIAN HAD TO LINE UP THE SIZE 4 RESECTION GUIDE TO THE PROPHECY BLOCK TO CREATE A NEW HOLE THAT MATCHED THE RESECTION BLOCK. THERE WAS A SURGICAL DELAY BECAUSE THE SURGEON HAD TO CREATE NEW HOLES IN THE PROPHECY BLOCK ESSENTIALLY RENDERING THEM USELESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15696374 ↗
• MalfunctionJul 18, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT THE LABEL ON THE ALIGNMENT GUIDE DID NOT MATCH THE PATIENT CASE NUMBER. THE GUIDE WAS LABELED FOR ANOTHER CASE.

  Patient problems: Insufficient Information

  MAUDE report 15042733 ↗