Tornier HRS ARS741809Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832093090), received between Oct 15, 2025 and Oct 15, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K191318); they may or may not involve this specific model.

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.

• InjuryOct 15, 2025Device Dislodged or Dislocated; Osseointegration Problem; Migration; Device Dislodged or Dislocated; Osseointegration Problem; Migration

  IT WAS REPORTED THAT EIGHT-MONTH POSTOPERATIVE IMAGING REVEALED GAPPING AT THE SURGICAL SITE. THE INITIAL ACCOUNT INDICATED THAT ONLY MODULAR COMPONENTS INCLUDING THE POLYETHYLENE INSERT, TRAY, LOCKING CAP, AND ASSEMBLY SCREW WERE EXCHANGED UNDER FLUOROSCOPIC GUIDANCE. HOWEVER, THIS WAS LATER CORRECTED TO REFLECT THAT THE ENTIRE HUMERAL CONSTRUCT WAS REMOVED AND REPLACED WITH A 230 MM CONSTRUCT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23301027 ↗
• InjuryOct 15, 2025Inadequacy of Device Shape and/or Size; Unstable; Inadequacy of Device Shape and/or Size; Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RSA REVISION CASE DUE TO RESORPTION/STABILITY ISSUES WITH THEIR REVIVE STEM AND PERFORM REVERSE CONSTRUCT. THE STEM WAS SWAPPED FOR A LARGER CONSTRUCT. THERE WAS NO MECHANICAL FAILURES WITH THEM IMPLANT. THE DOCTOR BLAMED IT ON THE PATIENT CONDITION.

  Patient problems: Joint Laxity

  MAUDE report 23300143 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191318. One submission often covers many models, so check the product and lot details in each record.

• Z-2020-2023 · Jun 12, 2023 · Open, Classified
  AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
• Z-2019-2023 · Jun 12, 2023 · Open, Classified
  AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101