Freedom Wrist Arthroplasty System 348291ERecalls & reported problems
Smith & Nephew, Inc. · CARPAL POLY. SIZE 1. STANDARD · 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 00885556856017), received between Oct 29, 2024 and Oct 29, 2024 — classified as 1 injury.
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
Patient problems
- Loss of Range of Motion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A WRIST PROTHESIS SURGERY THAT HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED LACK OF MOTION. THIS ADVERSE EVENT WILL BE TREATED BY A FUTURE REVISION SURGERY. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Loss of Range of Motion
MAUDE report 20559099 ↗
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/C-MStryker 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/R-RSStryker GmbH · PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED2 reports
- Universal 2™ Total Wrist System 261301Ascension Orthopedics, Inc. · Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained1 report
- Universal2 Total Wrist Implant System 262300Smith & Nephew, 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
- MAESTRO TOTAL WRIST 180151Biomet Orthopedics, LLC · PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED1 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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