KinematX 137-30001-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842078112014), received between Oct 24, 2023 and Jun 11, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A TOTAL WRIST IMPLANTED WHICH BEGAN CAUSING PAIN TWO YEARS LATER. AFTER REVIEWING OPTIONS, THE PATIENT WANTED THE IMPLANT REMOVED AND A FUSION INSTEAD.

  Patient problems: Implant Pain

  MAUDE report 22187471 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A "CLICK/CATCH" EXPERIENCED WHEN AT MAXIMUM FLEXION POST-OPERATIVE. THE DECISION WAS MADE BY THE SURGEON TO REVISE THE RADIAL STEM COMPONENTS' POSITION IN THE RADIUS. THE PATIENT HAD A DECADES-OLD MALUNION OF A DISTAL RADIUS FRACTURE, AND THE ORIGINAL PLACEMENT OF RADIAL COMPONENTS WAS COMMENSURATE TO THE HEALED ANATOMY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22127289 ↗
• MalfunctionJan 22, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT HAS A DISLOCATED IMPLANT. THE SURGEON COMMUNICATED THAT THE PATIENT WAS SEEN BY A PA AND AN X-RAY REVEALED THE DISLOCATION. BASED ON X-RAY REVIEW, SURGEON BELIEVES THAT PATIENT MIGHT HAVE HAD A FALL AS THERE WAS SOME DISTAL RADIUS BONE TRAUMA TO INDICATE THIS.

  Patient problems: Failure of Implant

  MAUDE report 18558046 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WITH RHEUMATOID ARTHRITIS WAS REPORTED TO HAVE AN INFECTION AND WAS BROUGHT TO SURGERY FOR WASHOUT AND EXCHANGE OF THE RADIAL BODY ASSEMBLY. TESTS FOR INFECTION, PARTICULATE AND METAL ALLERGY WERE ALL NEGATIVE. THE SURGEON REPORTED THAT THE IMPLANTS WERE SOLIDLY AFFIXED.

  Patient problems: Synovitis

  MAUDE report 17995380 ↗