NA 5791-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024192805), received between Aug 23, 2021 and Nov 7, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 20633428 ↗
• MalfunctionApr 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL KNEE PROCEDURE, A HEADED SCREW FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197273 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REPORTED EXPERIENCING PAIN AND INFLAMMATION IN THE KNEE APPROXIMATELY ONE YEAR POST-IMPLANTATION. A STEROID INJECTION WAS GIVEN IN THE KNEE DUE TO IMPINGEMENT OF THE FEMORAL IMPLANT ON THE IT BAND DUE TO OVERHANG. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Inflammation; Pain

  MAUDE report 12738527 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THIS ITEM WAS REPORTED IN ERROR. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED. THIS PRODUCT IS AN INSTRUMENT AND WAS NOT IMPLANTED INTO THE PATIENT.

  Patient problems: Inflammation; Pain

  MAUDE report 12738524 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REPORTED EXPERIENCING PAIN AND INFLAMMATION IN THE KNEE APPROXIMATELY ONE YEAR POST-IMPLANTATION. A STEROID INJECTION WAS GIVEN IN THE KNEE DUE TO IMPINGEMENT OF THE FEMORAL IMPLANT ON THE IT BAND DUE TO OVERHANG. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Inflammation; Pain

  MAUDE report 12738509 ↗
• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED PAIN, STIFFNESS, AND LIMITED RANGE OF MOTION THAT WAS UNRESOLVED WITH A MANIPULATION UNDER ANESTHESIA. THE PATIENT UNDERWENT A REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 12356166 ↗
• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED PAIN, STIFFNESS, AND LIMITED RANGE OF MOTION THAT WAS UNRESOLVED WITH A MANIPULATION UNDER ANESTHESIA. THE PATIENT UNDERWENT A REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 12356149 ↗