OrthAlign Plus 403087Recalls & reported problems
Orthalign, Inc. · Reference Sensor 4 · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00858704006589), received between Jul 3, 2019 and Oct 26, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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
- Incorrect, Inadequate or Imprecise Result or Readings2
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IN THE PREVIOUS CASE THE REFERENCE SENSOR WAS LEFT ON DURING IMPACTION. AFTER THAT THE NUMBERS SEEMED "OFF". WHEN THE SURGEON TRIED TO USE THE REFERENCE SENSOR IN THE NEXT CASE IT WOULD NOT PAIR WITH THE NAVIGATION UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18011916 ↗MalfunctionAug 9, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT TOTAL HIP ARTHROPLASTY WAS PERFORMED WITH HIPALIGN. DURING CUP IMPACTION, CR2 BATTERY WAS DEPLETED SO ANOTHER CR2 BATTERY WAS USED. THE SURGEON TRIED TO IMPACT CUP AGAIN AFTER HE ADJUSTED ANTEVERSION ANGLE BUT ANGLES NAVIGATION UNIT SHOWED WAS UNUSUAL THAT ABDUCTION ANGLE WAS OVER 50 DEGREE. SUBSEQUENTLY, HE IMPACTED THE CUP WITH ROUGH INDICATION. BALL JOINT OF THE PELVIC BASE CREST WAS FIRMLY FIXED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12294357 ↗MalfunctionJul 3, 2019No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT TOTAL HIP ARTHROPLASTY WAS PERFORMED WITH HIPALIGN. SURGEON INSTALLED A CUP TO THE PATIENT HIP WITH IMPACTOR CONNECTED TO THE REFERENCE SENSOR. HOWEVER, ANGLE OF THE CUP WAS SHOWN ABNORMALLY AFTER THE CUP INSTALLATION. SUBSEQUENTLY, CONVENTIONAL METHOD WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8759815 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.