TORNIER PERFORM™ REVERSED DWJ1017301Recalls & reported problems
Tornier, Inc. · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00846832085644), received between Jul 25, 2024 and Nov 25, 2025 — classified as 7 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 Problem5
- Device Dislodged or Dislocated1
- Loss of Osseointegration1
Patient problems
- Bone Fracture(s)3
- Implant Pain2
- Fever1
- Inadequate Osseointegration1
- Joint Dislocation1
- Joint Impingement1
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6) SHOULDER ID STUDY. SCAPULAR FRACTURE - ACROMIAL. PT BEGAN EXPERIENCING SEVERE LEFT SHOULDER PAIN STARTING AROUND (B)(6) 2025. CT COMPLETED ON (B)(6) 2025 SHOWED MINIMALLY DISPLACED FRACTURE OF THE ACROMION.
Patient problems: Bone Fracture(s); Pain
MAUDE report 23642358 ↗InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A REVISION SURGERY WAS PERFORMED DUE TO AN ACROMIAL STRESS FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 23578124 ↗InjuryOct 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
SUBJECT: (B)(6). SHOULDER ID STUDY. (B)(6) 2025. INSTABILITY, ANTERIOR DISLOCATION. PATIENT WAS FOUND TO HAVE A POST-OPERATIVE ANTERIOR SHOULDER DISLOCATION UPON X-RAY AT INITIAL POST-OPERATIVE VISIT. SHE WAS REVISED ON (B)(6) 2025.
Patient problems: Joint Dislocation
MAUDE report 23301016 ↗InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "SUBJECT: (B)(6). PT BEGAN EXPERIENCING CONSTANT SEVERE SHOULDER PAIN ON (B)(6) 2024. CT UNREMARKABLE. AS OF (B)(6) 2024. PATIENT STILL IS EXPERIENCING SHOULDER PAIN, BUT NO LONGER AS CONSTANT OR SEVERE."
Patient problems: Implant Pain
MAUDE report 21262258 ↗InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "SUBJECT: 003-011 SHOULDER ID STUDY. SCAPULAR FRACTURE - SCAPULAR SPINE (POST-OPERATIVE)".
Patient problems: Bone Fracture(s)
MAUDE report 21147065 ↗InjuryDec 20, 2024Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A REVISION SURGERY WAS PLANNED TO BE PERFORMED ON (B)(6) 2024, USING THE BLUEPRINT PLANNING FEATURE (CASE ID: (B)(4). THE POST OP X-RAYS SHOWED THE BASEPLATE WAS NOT SEATED. THE INITIAL BASEPLATE WAS REMOVED AND A NEW BASEPLATE AND GLENOSPHERE WERE IMPLANTED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 20995242 ↗InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6). SHOULDER ID STUDY. AS REPORTED: PATIENT REPORTED A "CATCHING" FEELING IN SHOULDER WITH INCREASED PAIN SINCE (B)(6) 2024. PT ALSO HAD A FEVER ON (B)(6) 2024; ANTIBIOTICS WERE PRESCRIBED FOR THIS. AS OF (B)(6) 2024, THE PATIENT REPORTED THAT HER SHOULDER PAIN IS IMPROVING.
Patient problems: Fever; Implant Pain; Joint Impingement
MAUDE report 19833647 ↗
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- 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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