AEQUALIS REVERSED DWB931Recalls & reported problems
Tornier · Class 2 · Implant
All models of AEQUALIS REVERSED (41)
Data updated Oct 18, 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 03700386916120), received between Nov 5, 2019 and May 27, 2025 — classified as 3 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Unspecified Infection2
- Joint Impingement1
- Joint Laxity1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OF A 2009 REVERSE TOTAL SHOULDER REPLACEMENT. REASON FOR REVISION WAS NOTCHING. HUMERAL COMPONENT WAS LOOSE. COMPONENTS CHANGED: GLENOSPHERE, HUMERAL STEM, UHMWPE LINER. SINGLE SCREW ALSO REMOVED FROM BASEPLATE AS NOTCHING FROM STEM WAS HITTING.
Patient problems: Joint Impingement; Joint Laxity
MAUDE report 22092326 ↗InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(6) 2016: RSA FOR ROTATOR CUFF TEAR. (B)(6) 2017: SUSPICION OF AN INFECTION. (B)(6) 2017: SUSPICION OF SUPPURATIVE ARTHRITIS. ALL THE IMPLANTS WERE REMOVED AND THE SURGEON PERFORMED DEBRIDEMENT AND FILLED THE SITE WITH A CEMENT CONTAINING ANTIBIOTICS. AS THE PATIENT HAS HAD AN INFECTION BEFORE, THEY HAD DONE THOROUGH TESTS AND ADMINISTERED MEDICINES TO THE PATIENT PRIOR TO THE OPERATION. THEY THINK THAT THE PATIENT WAS A CARRIER OF INFECTION AND GOT THE INFECTION. NO DEVICES WILL BE RETURNED.
Patient problems: Unspecified Infection
MAUDE report 13607005 ↗InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
"ON (B)(6) 2020, THIS PATIENT HAD A REVISION SURGERY BECAUSE INFECTION BY E. COLI WAS FOUND IN THE AFFECTED AREA AGAIN. WE HAVE NO X-RAYS. ALL THE IMPLANTS USED ON (B)(6) 2019, WERE REMOVED AND THE SURGERY WAS COMPLETED. THE DATA AT THE BELOW ARE THE IMPLANTS REMOVED ON (B)(6) 2020. ADDITIONAL REPORT TO # 3000931034-2019-00157".
Patient problems: Unspecified Infection
MAUDE report 9278759 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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