iTotal Identity CR RCR301111301Recalls & reported problems
Conformis, Inc. · ITOTAL IDENTITY CR REPLACEMENT TIBIAL TRAY (TITANIUM, CEMENTED), LEFT & RIGHT · Class 2 · Implant
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 M572RCR3011113011), received between May 14, 2026 and May 14, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Aseptic loosening1
- Limb Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE PATIENT CALLED TO LEAVE A COMPLAINT THAT THE KNEE NEVER FELT RIGHT 1-2 YEARS POST-OPERATIVELY. IN 2022, THE LEFT KNEE BECAME SWOLLEN AND BONE SCAN SHOWED PATELLA COMPONENT LOOSENING. OTHER COMPONENTS MAY BE LOOSENING TOO AND WILL REQUIRE A REVISION SURGERY.
Patient problems: Aseptic loosening; Limb Pain
MAUDE report 25177149 ↗
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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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