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iTotal PSRecalls & reported problems across all models

Conformis, Inc. · 2 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
365
Deaths reported
0
Injuries reported
354
Recalls
0

We found 2 models of iTotal PS by Conformis, Inc. in the FDA's device registry (GUDID). Together they are named in 365 adverse event reports in the FDA's MAUDE database, received between Mar 17, 2016 and Nov 10, 2022 — classified as 354 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (43 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported iTotal PS problems

Device problems

  • Adverse Event Without Identified Device or Use Problem102
  • Appropriate Device Problem Term/Code Not Available101
  • Loose or Intermittent Connection43
  • Insufficient Device Problem Information32
  • Loosening of Implant Not Related to Bone-Ingrowth22
  • Unstable14
  • Device Operates Differently Than Expected12
  • Noise, Audible11

Patient problems

  • Unspecified Infection98
  • No Code Available61
  • No Known Impact Or Consequence To Patient54
  • Insufficient Information50
  • Failure of Implant28
  • Loss of Range of Motion24
  • Pain15
  • No Information14

iTotal PS models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent iTotal PS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Conformis, Inc. products

All Conformis, Inc. devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page