NA 00-5850-060-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024196247), received between Nov 17, 2022 and Jun 11, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Pain; Pulmonary Embolism; Unspecified Infection

  MAUDE report 22183968 ↗
• InjuryMay 20, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TWO MONTHS POST IMPLANTATION DUE TO INFECTION AND LOOSENING OF FEMORAL AND ARTICULAR SURFACE PROSTHESIS. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 22052551 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A RIGHT TOTAL ROTATING HINGE KNEE ARTHROPLASTY PERFORMED AND SUBSEQUENTLY UNDERWENT TWO REVISION SURGERIES DUE TO DISASSOCIATION OF THE HINGE POST EXTENSION AS WELL AS A QUADRICEPS TENDON REPAIR PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS CONTINUED TO EXPERIENCE SIGNIFICANT PAIN WHICH INTERFERES WITH AMBULATION AND DAILY ACTIVITIES FOR TWO (2) YEARS FOLLOWING THE MOST RECENT PROCEDURE. NO ADDITIONAL MEDICAL INTERVENTION HAS BEEN REPORTED TO DATE TO ADDRESS THE CONTINUED PAIN. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 20523770 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A RIGHT TOTAL ROTATING HINGE KNEE ARTHROPLASTY PERFORMED AND SUBSEQUENTLY UNDERWENT TWO REVISION SURGERIES DUE TO DISASSOCIATION OF THE HINGE POST EXTENSION. APPROXIMATELY THREE (3) WEEKS FOLLOWING THE SECOND REVISION SURGERY, THE PATIENT PRESENTED WITH SIGNIFICANT PREPATELLAR SWELLING AND UNDERWENT ADDITIONAL SURGERY TO REPAIR THE QUADRICEPS TENDON. DURING THE PROCEDURE, PREPATELLAR BURSITIS WAS REMOVED, AND TWO AREAS OF PARTIAL RUPTURE OF THE VASTUS MEDIALIS OFF THE QUADRICEPS TENDON WERE NOTED. THERE WERE NO CONCERNS WITH THE IMPLANTS WHICH WERE ALL RETAINED. THE TENDON WAS REPAIRED WITHOUT COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Bursitis; Muscle/Tendon Damage; Swelling/ Edema

  MAUDE report 20523405 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, TWO MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION. A WASHOUT WAS PERFORMED AND THE ARTICULAR SURFACE WAS EXCHANGED. THE TIBIAL TUBERCLE TISSUE WAS ALSO REATTACHED AS THE INFECTION HAD CAUSED A PREVIOUS REPAIR PROCEDURE TO FAIL. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 18442552 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 17914803 ↗
• InjuryNov 17, 2022Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION RIGHT TOTAL KNEE ARTHROPLASTY TO REPLACE A DISASSOCIATED HINGE POST. A POLYETHYLENE BEARING WAS IMPLANTED WITH A HINGE POST PACKAGED WITH ANOTHER DEVICE. APPROXIMATELY FOUR AND A HALF MONTHS POST IMPLANTATION, THE HINGE POST OF THE ARTICULAR SURFACE BACKED OUT FOR A SECOND TIME. THE PATIENT AGAIN UNDERWENT REVISION SURGERY TO REPLACE THE ARTICULAR SURFACE AND HINGE POST MECHANISM. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 15814934 ↗