REMOTION WA/C-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886385015514), received between Aug 21, 2018 and Aug 21, 2018 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2018Break; Loose or Intermittent Connection

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NATIONAL JOINT REPLACEMENT REGISTRY OF THE AUSTRALIAN 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 7803364 ↗