AEQUALIS™ FLEX REVIVE™ ARS741802Recalls & reported problems
Tornier, Inc. · Class 2 · Implant
All models of AEQUALIS FLEX REVIVE (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00846832069606), received between Dec 10, 2020 and Aug 15, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Loosening of Implant Not Related to Bone-Ingrowth2
Patient problems
- Bone Fracture(s)1
- Implant Pain1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD POST-OP COMPLICATIONS FOLLOWING AN INTRAOPERATIVE GT FRACTURE. THE PATIENT UNDERWENT RE-OPERATION WITHOUT COMPONENT CHANGE. ORIF OF GT FRACTURE; OUTCOME IS ONGOING.
Patient problems: Bone Fracture(s); Unspecified Infection
MAUDE report 15224765 ↗InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT PATIENT HAD PAIN ("WORSENING PAIN") IN THE RIGHT SHOULDER. POST-OPERATIVE COMPLICATION 5 MONTHS AFTER PREVIOUS SURGERY. ACTION TAKEN: MEDICATION ; INJECTION- 1ML KENALOG, 2ML LIDOCAINE, 7ML ROPIVICAINE. PATIENT IS ALSO SEEING A NEUROLOGIST AND WILL FOLLOW UP WITH US AFTER 3 MONTHS.
Patient problems: Implant Pain
MAUDE report 13472504 ↗InjuryDec 10, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON THE SHOULDER. ALLEGEDLY THE PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING/LYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10988149 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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