iTotal Identity 3DP Porous Knee TCR-000-D005-020111Recalls & reported problems
Restor3d, Inc. · iTotal Identity CR 3DP Porous iJigs Right · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840097515168), received between Jul 30, 2026 and Jul 30, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).
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
- Inadequacy of Device Shape and/or Size1
Patient problems
- Limb Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2026Inadequacy of Device Shape and/or Size
The surgeon reported that the tibial resection guide placed resection in varus and had to manually correct the resection, but the final outcome was still in varus. Postoperatively, the patient presented with patellar "clunking" and the surgeon feels this is caused by the varus tibial resection and mal-rotation. The surgeon plans to revise the tibial side of the construct to resolve the issue.
Patient problems: Limb Pain
MAUDE report 50090425 ↗
Other Knee Arthroplasty Implantation System devices
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR111111102Conformis, Inc. · Knee Arthroplasty Implantation System390 reports
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR111SPEC02Conformis, Inc. · Knee Arthroplasty Implantation System11 reports
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR121SPEC02Conformis, Inc. · Knee Arthroplasty Implantation System11 reports
- TRUMATCH 42-0906Depuy (Ireland) · Knee arthroplasty implantation system5 reports
- iTotal® Identity Cruciate Retaining Knee Replacement System TCR301111301Conformis, Inc. · Knee Arthroplasty Implantation System3 reports
- iTotal® CR iPoly™ Insert Kit RCR010080003Conformis, Inc. · Knee Arthroplasty Implantation System1 report
- VISIONAIRE V0200128Smith & Nephew, Inc. · Knee arthroplasty implantation system1 report
- iTotal Identity CR RCR301111301Conformis, Inc. · Knee Arthroplasty Implantation System1 report
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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