Optimotion Blue CR HCCR Total Knee System 1014-B-0400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B6961014B04000), received between Aug 25, 2021 and Aug 25, 2021 — 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.

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.

• InjuryAug 25, 2021Inadequacy of Device Shape and/or Size; Inadequate or Insufficient Training; Misassembled During Installation; Inadequacy of Device Shape and/or Size; Inadequate or Insufficient Training; Misassembled During Installation

  USER REPORTED EVENT OF TIBIAL STEM DISASSOCIATION FROM A TIBIAL BASEPLATE. THE USER IS A HEALTHCARE PROFESSIONAL WHO DETERMINED THAT THE PATIENTS WERE, "OBESE AND SUSTAINED CATASTROPHIC SETTLING/FRACTURE OF THE BONE UNDERNEATH THE BASE PLATE WHICH IS WHAT I ATTRIBUTE TO THE DISLODGEMENT OF THE TIBIAL STEM FROM THE BASEPLATE". THIS INJURY REQUIRED REVISION SURGERY TO RESTORE OSSEOINTEGRATION. USER REPORT SUGGESTS THAT THE "BASE PLATE WAS HUGELY UNDERSIZED AND MALPOSITIONED". THIS EVENT OCCURRED CONCURRENTLY IN ONE ADDITIONAL PATIENT WHERE THE IMPLANTS WERE INSTALLED (29 DAYS APART) BY THE SAME SURGEON (WHO IS NOT THE REPORTING USER). ADDITIONAL COMMUNICATION ON 7/23/2021 CONFIRMED THAT, "[INSTALLING SURGEON] CONFIRMS BY RADIOGRAPHIC EXAMINATION THAT HE HAS GROSSLY UNDERSIZED [PATIENT]." IN THE INITIAL COMMUNICATION THE USER INDICATED THEIR, "SUSPICION IS THAT OUR OPERATING TEAM DID NOT IMPACT THE STEM SUFFICIENTLY TO THE TIBIAL TRAY AND WHEN THERE WAS CATASTROPHIC SETTLING FORCES CAUSED THE STEM TO DISENGAGE". ADDITIONAL COMMUNICATION ON 7/23/2021 CONFIRMED THAT JUST PRIOR TO THE EVENT, "SURGEONS HAD TRANSITIONED TO ALLOWING THE SURGICAL TECHS TO IMPACT THE STEM. THE TECHS WERE TAUG

  Patient problems: Bone Fracture(s)

  MAUDE report 12365936 ↗