Katalyst Biopolar Radial Head System 221424Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556827321), received between Feb 19, 2024 and Feb 19, 2024 — classified as 1 injury.

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 16, 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.

• InjuryFeb 19, 2024Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, PATIENT UNDERWENT A PRIMARY LEFT CATALYST BIPOLAR RADIAL SYSTEM ON (B)(6) 2022 DUE TO FRACTURE. HE WAS IN PAIN IN THE ELBOW AND BEGAN HAVING PAIN IN THE WRIST. HE WAS FOUND TO HAVE A FILED RADIAL HEAD ARTHROPLASTY WITH LOOSE HARDWARE. HE ALSO WAS FOUND TO HAVE SHORTENED OF THE RADIUS RELATIVE THE ULNA. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6 2023, IN WHICH THE 24MM CATALYST RADIAL HEAD AND 7.5MM CATALYST STEM WERE EXPLANTED. FOUND TO BE SIGNIFICANT ARTHRITIS OF THE CAPITELLUM. THERE WAS SIGNIFICANT AMOUNT OF METALLOSIS WITHIN THE SYNOVIUM OF THE JOINT. X-RAYS OF THE RADIOCAPITELLAR JOINT DEMONSTRATED GOOD ALIGNMENT OF THE IMPLANT WITH NO OVERSTUFFING. X-RAYS OF THE WRIST DEMONSTRATED IMPROVEMENT OF THE ULNAR VARIANCE ALTHOUGH THERE IS STILL SOME RESIDUAL ULNAR POSITIVITY. THE ELBOW WAS TAKEN THROUGH RANGE OF MOTION AND FOUND TO BE STABLE. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND THE TOURNIQUET WAS DEFLATED. BROUGHT BACK TO THE POSTOPERATIVE CARE UNIT IN STABLE CONDITION.

  Patient problems: Failure of Implant; Joint Dislocation; Joint Laxity; Metal Related Pathology; Pain

  MAUDE report 18735602 ↗