KinematX 115-21000-SRecalls & reported problems
Extremity Medical, LLC · KinematX Radial Stem - Size 2; Sterile Packed · 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 00842078111529), received between Dec 13, 2023 and Dec 13, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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
- Patient-Device Incompatibility1
Patient problems
- Implant Pain1
- Joint Impingement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 13, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT WAS EXPERIENCING PERSISTENT PAIN WHEN FLEXING THE WRIST PAST 30 DEGREES. THE IMPLANT SEEMED TO SUBLUX AND GET "LOCKED". THE PATIENT WOULD THEN NEED TO PULL ON HIS WRIST TO "UNLOCK" AND THEN CAN EXTEND. THIS WAS FIRST NOTICED ABOUT 3 MONTHS POST-OP AS THE PATIENT STARTED TO USE AND MOVE THE WRIST MORE. PATIENT HAD A PRIOR DISTAL RADIUS NON-UNION CAUSING DEFORMITY.
Patient problems: Implant Pain; Joint Impingement
MAUDE report 18322739 ↗
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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