REMOTION WA/R-RSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886385015583), received between Aug 21, 2018 and Sep 18, 2019 — classified as 2 injuries.

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

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2019Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration

  AS REPORTED: "DEMOTION WRIST REMOVAL PATIENT PRESENTED TO HOSPITAL WITH REGARD TO KNEE JOINT PAIN, INVESTIGATION REVEALED CHRONIC WRIST PAIN AND POSSIBLE INFECTION AS REPORTED BY PLASTICS DEPARTMENT."

  Patient problems: Arthralgia; Pain; Unspecified Infection

  MAUDE report 9085069 ↗
• InjuryAug 21, 2018Break; Loose or Intermittent Connection

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NATIONAL JOINT REPLACEMENT REGISTRY OF THE (B)(6) ORTHOPEDIC ASSOCIATION. THE REPORT IS ASSOCIATED WITH THE REMOTION SYSTEM, WITHIN THAT REPORT, 3 POST-OPERATIVE COMPLICATIONS/ REVISIONS WERE REPORTED, WHICH OCCURRED IN 2008, 2009 AND 2013. THE REASON FOR REVISION WERE LOOSENING (1 CASE), IMPLANT BREAKAGE WRIST PLATE (1 CASE) AND INFECTION (1 CASE). A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 3 COMPLAINTS WERE INITIATED RETROSPECTIVELY. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7803367 ↗