Tornier Simpliciti® Shoulder System DWG401Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00846832091874), received between Jun 8, 2022 and Aug 28, 2024 — classified as 4 injuries.

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.

• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A REVISION SURGERY DUE TO AN INFECTION CAUSED BY P. ACNES, AS IDENTIFIED BY THE BACTERIAL CULTURE. NO OTHER CONTRIBUTING FACTORS WERE REPORTED, AND THE IMPLANTS WERE DISCARDED AFTER THE PROCEDURE.

  Patient problems: Bacterial Infection

  MAUDE report 20091920 ↗
• InjuryDec 22, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT SUFFERED A ROTATOR CUFF TEAR (SIGNIFICANT / NOT PRESENT PRE-OP)- PATIENT HAS BEEN EXPERIENCING PAIN CONSISTENT WITH ROTATOR CUFF PATHOLOGY. X-RAYS SHOW SUPERIOR HUMERAL MITIGATION ALSO CONSISTENT WITH ROTATOR CUFF PATHOLOGY.

  Patient problems: Implant Pain; Muscle/Tendon Damage

  MAUDE report 18383618 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED A INTRAOPERATIVE GT FRACTURE THAT WAS TREATED WITH GT ORIF SUTURE CERCLAGE.

  Patient problems: Limb Fracture

  MAUDE report 18381545 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN AND WAS DIAGNOSED WITH ROTATOR CUFF DEFICIENCY. THE PATIENT HAD A REVISION SURGERY.

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 14632723 ↗