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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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.