TORNIER PERFORM™ REVERSED DWJ1017303Recalls & reported problems
Tornier, Inc. · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832085668), received between Mar 12, 2024 and Nov 11, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration1
- Joint Impingement1
- Joint Laxity1
- Osteolysis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6) SHOULDER ID STUDY. (B)(6) 2025 POST-OPERATIVE ADVERSE EVENT: SCAPULAR NOTCHING NARRATIVE: PATIENT WAS FOUND TO HAVE A LOOSE HUMERAL COMPONENT IN THE SETTING OF EARLY SCAPULAR NOTCHING AT AN UNSCHEDULED VISIT 1.5 YEARS AFTER SURGERY.
Patient problems: Joint Impingement; Joint Laxity
MAUDE report 23525967 ↗InjuryMar 12, 2024Loss of Osseointegration; Loss of Osseointegration
THE PATIENT INITIALLY HAD A ZB HEMI SHOULDER REPLACEMENT. THE LONG ZB STEM WAS REMOVED, AND A REVIVE WITH PERFORM REVERSE IMPLANT WAS IMPLANTED. THE PATIENT LATER REQUIRED A SECOND REVISION TO A REVIVE HEMI FROM TORNIER REVIVE WITH PERFORM REVERSE DUE TO SIGNIFICANT PROXIMAL BONE RECESSION. THE STEM WAS WELL FIXED, SO EVERYTHING ON THE GLENOID SIDE WAS REMOVED, AND A 52 X 23 FLEX HEAD WAS INSTALLED.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 18889444 ↗
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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