iTotal Identity PS TPS-101-111211Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M572TPS1011112111), received between Aug 5, 2022 and Jul 16, 2026 — classified as 4 injuries.

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REQUIRES REVISION SURGERY DUE TO PATIENT INFECTION AFTER TOTAL KNEE REPLACEMENT. THE COMPONENTS WERE MANUFACTURED, PACKAGED, AND STERILIZED CORRECTLY AND IT IS NOT BELIEVED THAT THE IMPLANT CAUSED THE INFECTION AND SUBSEQUENT REVISION.

  Patient problems: Septic loosening

  MAUDE report 25840725 ↗
• InjuryNov 18, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PS FEMORAL IMPLANT PACKAGING HAD A HOLE THROUGH BOTH LAYERS OF PACKAGING, BREACHING THE STERILE BARRIER. THIS WAS DISCOVERED DURING SURGERY; THE SURGEON CHOSE TO RE-STERILIZE THE IMPLANT. THIS RE-STERILIZATION PROCESS TAKES AROUND 1-2 HOURS AND NEEDED TO BE COMPLETED WHILE THE PATIENT WAS UNDER ANESTHESIA. THIS WAS A MAJOR DELAY TO THE SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15829374 ↗
• InjuryOct 25, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS LAXITY. PRIMARY SURGERY OCCURRED ON (B)(6) 2022. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.

  Patient problems: Joint Laxity

  MAUDE report 15670651 ↗
• InjuryAug 5, 2022Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT REPLACEMENT POLY INSERTS HAVE BEEN REQUESTED FOR REVISION SURGERY. REASON FOR REVISION IS LAXITY. PRIMARY SURGERY OCCURRED ON (B)(6) 2021. REVISION SURGERY IS PLANNED FOR (B)(6) 2022.

  Patient problems: Joint Laxity

  MAUDE report 15180477 ↗