Katalyst Bipolar Radial Head System 221421Recalls & reported problems
Smith & Nephew, Inc. · 21MM KATALYST RADIAL HEAD · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556827314), 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
Patient problems
- Failure of Implant1
- Inadequate Osseointegration1
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; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, PATIENT EXPERIENCE CHRONIC ESSEX-LOPRESTI INJURY, LEFT FOREARM AND A FAILED LEFT ELBOW RADIAL HEAD ARTHROPLASTY. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2023, IN WHICH THE 21MM KATALYST RADIAL HEAD AND 6MM KATALYST STEM WERE EXPLANTED. THE ELBOW WAS TAKEN THROUGH A FULL RANGE OF MOTION AND APPEARED TO BE MUCH MORE STABLE WITH GOOD RESTORATION OF A NEUTRAL ULNAR VARIANCE. SATISFIED WITH THE RECONSTRUCTION OF THE ELBOW JOINT. THEN, REPAIRED THE LATERAL LIGAMENT COMPLEX IN THE TENDON, THE MUSCLES UTILIZING 2-0 FIBERWIRE INTERRUPTED SUTURE. THAT SIGNIFICANTLY INCREASED THE STABILITY, WE WERE ABLE TO GET FULL FLEXION, FULL PRONATION AND SUPINATION AND EXTENSION WITHIN ABOUT 15 DEGREES WITHOUT ANY SUBLUXATION. SATISFIED WITH THE RECONSTRUCTION OF INTEROSSEOUS LIGAMENT, THE FOREARM WAS TAKEN THROUGH ITS MOTION WITH NO SUBLUXATION, NO INSTABILITY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 18735706 ↗
Other PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER devices
- EVOLVE 496S275Wright Medical Technology, Inc. · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall6 reports
- NA 09.405.966SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall2 reports
- NA 03.405.000SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall2 reports
- EXPLOR 11-210061Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.250SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.263SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.583SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
- NA 09.405.570SSynthes GmbH · PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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