iTotal® PS iPoly™ Insert Kit RPS010140001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M572RPS0101400011), received between Nov 3, 2025 and Nov 3, 2025 — classified as 1 injury.

6 other recalls cover devices cleared under the same FDA submission (K142161, K142404); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT UNDERWENT A PRIMARY TOTAL KNEE ON (B)(6) 2021. PATIENT HAS DEVELOPED GLOBAL INSTABILITY AND NEEDS POLY EXCHANGE.

  Patient problems: Joint Laxity

  MAUDE report 23458814 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142161, K142404. One submission often covers many models, so check the product and lot details in each record.

• Z-1070-2016 · Jan 28, 2016 · Terminated
  Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
• Z-0144-2016 · Aug 31, 2015 · Terminated
  ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111
• Z-0141-2016 · Aug 31, 2015 · Terminated
  ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS)
• Z-0147-2016 · Aug 31, 2015 · Terminated
  ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111
• Z-0146-2016 · Aug 31, 2015 · Terminated
  ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
• Z-0145-2016 · Aug 31, 2015 · Terminated
  ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)