Universal2 Total Wrist Implant System 262300Recalls & reported problems
Smith & Nephew, Inc. · CARPAL POLY MEDIUM- STD. · Class 2 · Implant
- 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 00885556865019), received between Feb 28, 2025 and Feb 28, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Degraded” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Degraded1
- Fracture1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 28, 2025Degraded; Fracture; Degraded; Fracture
IT WAS REPORTED THAT, AFTER A WRIST ARTHROPLASTY ON (B)(6) 2022, THE PATIENT'S S&N (INTEGRA) CARPAL POLY MEDIUM- STD HAD EXCESSIVE WEAR. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2025 IN WHICH THE SYSTEM WAS EXPLANTED AND REVISED TO A SWEMAC MOTEC. THE CURRENT PATIENT'S STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21491558 ↗
Other Prosthesis, wrist, 3 part metal-plastic-metal articulation, semi-constrained devices
- KinematX 137-30001-SExtremity Medical, LLC · Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained4 reports
- REMOTION WA/R-RSStryker GmbH · PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED2 reports
- KinematX 137-30002-SExtremity Medical, LLC · Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained2 reports
- REMOTION WA/C-MStryker GmbH · PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED2 reports
- Freedom Wrist Arthroplasty System 348291ESmith & Nephew, Inc. · Prosthesis, wrist, 3 part metal-plastic-metal articulation, semi-constrained1 report
- KinematX 137-50012-SExtremity Medical, LLC · Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained1 report
- Universal 2™ Total Wrist System 261301Ascension Orthopedics, Inc. · Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained1 report
- Integra® Freedom Wrist Arthroplasty System 348292Ascension Orthopedics, Inc. · Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.