P.F.C. 86-6403Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295216919), received between Nov 13, 2019 and Sep 13, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2022Fracture; Device-Device Incompatibility; Unintended Movement; Fracture; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT AN X-RAY IMAGE SHOWED A METAL COMPONENT OF THE REAMING DEVICE HAD COME LOOSE AND REMAINED IN THE FEMUR.

  Patient problems: Insufficient Information

  MAUDE report 15409914 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. NO INDICATION OF A PROBLEM WITH THE PRODUCTS. DOI: (B)(6) 2021 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12962955 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS (INCLUDING THE CROSSED OUT TIBIAL INSERT) WERE REVISED. THE REASON FOR REVISION WAS FOR FIXED FLEXION DEFORMITY. THE DATE OF ORIGINAL SURGERY WAS (B)(6) 2010. THERE WAS NO SIGN OF WEAR, THE IMPLANTS ARE NOT AVAILABLE FOR RETURN. THE SURGEON DOES NOT REQUIRE ANY FOLLOW UP.

  Patient problems: Joint Contracture; Loss of Range of Motion; Muscular Rigidity

  MAUDE report 12054471 ↗
• InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TREATED WITH A KNEE REPLACEMENT ON THE (B)(6) 2019. PATIENT WAS ADMITTED TO HOSPITAL DUE TO AN INFLAMMATION IN THE KNEE. REVISION SURGERY PLANNED FOR THE (B)(6) 2020. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Inflammation; No Code Available

  MAUDE report 10014832 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL KNEE WITH MEDIAL CONDOLENCES BONE LESION. DOI: (B)(6) 2005; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Injury; No Code Available; Pain

  MAUDE report 9315794 ↗