CORIOGRAPH ROB20030Recalls & reported problems
Smith & Nephew, Inc. · CORIOGRAPH PRE-OP PLANNING AND MODELING SERVICE · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556917442), received between Aug 22, 2024 and Dec 9, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Application Program Problem: Parameter Calculation Error” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Application Program Problem: Parameter Calculation Error2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2025Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error
IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI TKA SURGERY, THE CORIOGRAPH PRE-OP SERVICES PLAN INDICATED A SIZE 5 J2 BCS FEMUR, WITH PLANNED POSTERIOR RESECTIONS OF 9.0 MM MEDIALLY AND 7.5 MM LATERALLY, SET AT 0° REFERENCING THE PCA. HOWEVER, AFTER REGISTRATION, THE INITIAL POSTERIOR CUTS DISPLAYED WERE 12.5 MM MEDIALLY AND 7.5 MM LATERALLY, ALSO AT 0° REFERENCING THE PCA. DUE TO THIS DISCREPANCY, IT WAS VERIFY USING THE MANUAL SIZING GUIDE. THE GUIDE CONFIRMED A SIZE 5 FEMUR. THE PROCEDURE WAS RESUMED, AS NORMAL, AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23756572 ↗MalfunctionAug 22, 2024Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error
IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY WITH CORIOGRAPH, THE FEMUR MODEL WAS UNABLE TO POPULATE WHILE COLLECTING DATA POINTS. THE MODEL WOULD JUMP BETWEEN LOOKING LIKE A LOT IS FILLED IN, BACK TO MISSING MULTIPLE PLACES WITH CRITICAL BLUE AREAS. MORE THEN ENOUGH DATA SHOULD HAVE BEEN PROVIDED FOR THE MODEL TO GENERATE. AFTER THE SURGEON DECIDED TO CONVERT TO AN IMAGE LESS PROCEDURE THE MODEL APPEARED TO GENERATE WITH ALL THE DATA COLLECTED, SHOWING A NORMAL FEMUR MODEL. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20031656 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.