ORTHOMAP 6007-616-000Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · VERSATILE HIP 2.0 SOFTWARE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327004250), received between Feb 22, 2019 and Nov 7, 2025 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Image Display Error/Artifact” (10 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Image Display Error/Artifact10
- Imprecision8
- Incorrect Measurement1
Patient problems
- No Consequences Or Impact To Patient10
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2025Incorrect Measurement; Incorrect Measurement
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23500570 ↗MalfunctionSep 26, 2019Image Display Error/Artifact; Imprecision; Image Display Error/Artifact; Imprecision
IT WAS REPORTED BY THE USER FACILITY THAT DURING A PROCEDURE, THERE WAS AN INACCURACY BY THE DEVICE, AND AT ONE POINT THE INACCURACY WAS 15MM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9124799 ↗MalfunctionSep 26, 2019Image Display Error/Artifact; Imprecision; Image Display Error/Artifact; Imprecision
THE USER FACILITY REPORTED THE DEVICE WAS INACCURATE DURING A CASE; THE DOCTOR REAMED TO 3MM SHORT OF THE MOST MEDIAL ASPECT AND RECORDED IT AS THE NEW ZERO. DURING CUP INSERTION, IT WAS REPORTED THAT THERE WAS 10MM DISTANCE TO REACH THE NEW ZERO. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9123963 ↗MalfunctionSep 3, 2019Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED THAT THE DEVICE HAD DEPTH TO SEAT ACCURACY ISSUES. THERE WERE NO REPORTED ADVERSE CONSEQUENCES; THERE WERE NO SIGNIFICANT PROCEDURE DELAYS; THERE WAS NO MEDICAL INTERVENTION REQUIRED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8956760 ↗MalfunctionAug 19, 2019Image Display Error/Artifact; Imprecision; Image Display Error/Artifact; Imprecision
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DEPTH TO SEAT WAS SHOWING AN INACCURATE VALUE, DURING TOTAL HIP WHILE USING VERSATILE HIP SOFTWARE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8905778 ↗MalfunctionJul 12, 2019Image Display Error/Artifact; Imprecision; Image Display Error/Artifact; Imprecision
IT WAS REPORTED THAT THE SURGEON'S DEPTH TO SEAT NUMBERS WERE INCREASING WHEN THY IMPACTED THE CUP DEEPER AS OPPOSED TO DECREASING. THERE WERE NO REPORTED ADVERSE CONSEQUENCES; THERE WERE NO PROCEDURE DELAYS; THERE WAS NO MEDICAL INTERVENTION REQUIRED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8785903 ↗MalfunctionJul 12, 2019Image Display Error/Artifact; Imprecision; Image Display Error/Artifact; Imprecision
IT WAS REPORTED THAT THE SURGEON'S DEPTH TO SEAT NUMBERS WERE INCREASING WHEN THY IMPACTED THE CUP DEEPER AS OPPOSED TO DECREASING. THERE WERE NO REPORTED ADVERSE CONSEQUENCES; THERE WERE NO PROCEDURE DELAYS; THERE WAS NO MEDICAL INTERVENTION REQUIRED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8785902 ↗MalfunctionJun 26, 2019Image Display Error/Artifact; Imprecision; Image Display Error/Artifact; Imprecision
IT WAS REPORTED BY THE USER FACILITY THAT DURING A PROCEDURE, THERE WAS AN INACCURACY BY THE DEVICE, AND AT ONE POINT THE INACCURACY WAS 15MM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8736500 ↗MalfunctionApr 29, 2019Image Display Error/Artifact; Imprecision; Image Display Error/Artifact; Imprecision
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DEPTH OF THE HIP SOFTWARE WAS OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8560138 ↗MalfunctionApr 29, 2019Image Display Error/Artifact; Imprecision; Image Display Error/Artifact; Imprecision
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DEPTH OF THE HIP SOFTWARE WAS OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8560136 ↗MalfunctionFeb 22, 2019Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED BY THE USER FACILITY THAT DURING A LEG LENGTH VERIFICATION POST PROCEDURE, THERE WAS AN INACCURACY BY THE DEVICE. THE DEVICE REFLECTED A LENGTH THAT WAS LONGER THAN THE ACTUAL LENGTH. THE EXACT INACCURACY WAS UNKNOWN, BUT LESS THAN 11MM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8362670 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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