iDuo BKA-111-111102Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M572BKA1111111021), received between Feb 21, 2017 and Jan 23, 2020 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Align” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K093513); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD POST-OP LOOSENING OF THE TIBIAL BASEPLATE. THE PATIENT'S KNEE WAS REVISED TO AN OFF-THE-SHELF IMPLANT BY A NON-CONFORMIS SURGEON.

  Patient problems: No Information

  MAUDE report 9623864 ↗
• InjurySep 24, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SURGEON IMPLANTED THE FEMORAL COMPONENT, BUT WAS NOT COMFORTABLE WITH THE TIBIAL RESECTION FOR THE TIBIAL IMPLANT. HE CONVERTED TO AN OFF-THE-SHELF IMPLANT TO COMPLETE THE SURGERY SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9109560 ↗
• MalfunctionAug 30, 2019Failure to Align

  IT WAS REPORTED THAT THE TIBIAL PREP GUIDE DID NOT MATCH LUG AND KEEL PATTERN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8950606 ↗
• InjuryMar 28, 2019Moisture Damage

  IT WAS REPORTED THAT THERE WERE SMALL AMOUNTS WATER OR A LIQUID IN THE PACKAGING OF THE IDUO ORANGE AND BLUE SPACER PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8461901 ↗
• InjuryFeb 21, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. A REVISION SURGERY IS PLANNED TO EXCHANGE THE POLY INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 6346091 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093513. One submission often covers many models, so check the product and lot details in each record.

• Z-0143-2016 · Aug 31, 2015 · Terminated
  ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) M5723INT0600220 (OUS)
• Z-0142-2016 · Aug 31, 2015 · Terminated
  ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230
• Z-0148-2016 · Aug 31, 2015 · Terminated
  ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS)