NA 1294-35-325Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295026037), received between Jul 26, 2018 and Nov 29, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE PRIMARY SURGERY. THIS PC REPORTS ABOUT THE REMOVAL SURGERY DUE TO INFECTION. AFTER THE REVISION TKA SURGERY PERFORMED ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL SURGERY ON (B)(6) 2021 BECAUSE INFECTION OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12882772 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE THE PATIENT HAD A TOTAL IMPLANT EXPLANTED, CONVERT TO ANTIBIOTIC SPACER DUE TO INFECTION. POLY INSERT CHANGED ON (B)(6) 2019 FROM PREVIOUS INFECTION. DOI: (B)(6) 2019 ALL EXPLANTED PRODUCTS, DOI: (B)(6) 2019 TIBIAL INSERT, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11917916 ↗
• InjurySep 12, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE IMPLANTS DISLOCATED AND CAUSED A TIBIAL FRACTURE TO PATIENT. FEMUR REVISED TO SROM HINGE AND NEW MBT THICK TRAY. SLEEVE AND STEM WERE IMPLANTED. PATIENT CAME TO THE EMERGENCY ROOM ON (B)(6) 2018 WITH DISLOCATION AND FRACTURE. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Bone Fracture(s); Not Applicable

  MAUDE report 7869226 ↗
• InjuryJul 26, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT UNDERWENT A LEFT KNEE REPLACEMENT ((B)(4) WAS USED) ON (B)(6) 2014. NO PART/LOT INFORMATION OR OPERATIVE NOTE WAS PROVIDED. AT THIS TIME THERE IS NO ALLEGATIONS OR COMPLICATIONS NOTED AFTER THE PRIMARY OPERATION. DOI: (B)(6) 2014; DOR: NO REVISION; (LEFT KNEE).

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7723700 ↗