TORNIER PERFORM™ REVERSED DWJ1017302Recalls & reported problems
Tornier, Inc. · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00846832085651), received between May 13, 2024 and Nov 27, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 Problem3
- Device Dislodged or Dislocated1
Patient problems
- Joint Dislocation1
- Numbness1
- Post Operative Wound Infection1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6) SHOULDER ID STUDY. INFECTION - DEEP. SUBJECT WAS FOUND TO HAVE GLENOID BASEPLATE LOOSENING AND INFECTION AT UNSCHEDULED 6-MONTH POST-OPERATIVE VISIT.
Patient problems: Unspecified Infection
MAUDE report 23665743 ↗InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED USING THE BLUEPRINT PLANNING FEATURE. THE PATIENT HAD PREVIOUSLY UNDERGONE A PRIMARY SHOULDER PROCEDURE INVOLVING STRYKER/TORNIER IMPLANTS. FOLLOWING THE INITIAL SURGERY, THE PATIENT DEVELOPED AN INFECTION, AND ALL IMPLANTS WERE EXPLANTED WITH PLACEMENT OF AN ANTIBIOTIC SPACER. THE REVISION PROCEDURE INVOLVED REMOVAL OF THE SPACER AND CONVERSION TO A REVERSE SHOULDER ARTHROPLASTY.
Patient problems: Post Operative Wound Infection
MAUDE report 23346445 ↗InjuryFeb 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "SUBJECT: (B)(6) SHOULDER ID STUDY. SENSORY AND/OR MOTOR DISTURBANCE - BRANCH NEUROPATHY PT REPORTED THAT 2 WEEKS POST-OP, HE BEGAN EXPERIENCING NUMBNESS IN HIS RIGHT RING AND PINKY FINGERS."
Patient problems: Numbness
MAUDE report 21488529 ↗InjuryMay 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION SURGERY PERFORMED INVOLVING THE REMOVAL OF STRYKER/TORNIER PRODUCTS, SPECIFICALLY THE GLENOSPHERE, TRAY, AND POLY IMPLANTS, DUE TO PATIENT DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 19303806 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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