TORNIER PERFORM™ HUMERAL SYSTEM DWT100Recalls & reported problems
Tornier, Inc. · Class 2 · Implant
All models of TORNIER PERFORM HUMERAL SYSTEM (68)
Data updated Oct 18, 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 00846832085088), received between Mar 8, 2023 and Nov 26, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
- Unstable1
Patient problems
- Hematoma1
- Insufficient Information1
- Joint Laxity1
- Muscle/Tendon Damage1
- Nonunion/Delayed-union Bone Fracture1
- Pain1
- Subluxation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6), PERFORM HUMERAL SYSTEM STUDY (PHS). HEMATOMA: SUBJECT EXPERIENCED A HEMATOMA WITH DRAINAGE.
Patient problems: Hematoma
MAUDE report 23654371 ↗InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6). PERFORM HUMERAL SYSTEM STUDY (PHS). UNEXPECTED PAIN NOT RELATED TO SURGICAL RECOVERY. SUBJECT REPORTED PAIN AT THEIR STUDY VISIT. THE PAIN MAY BE RELATED TO OVERUSE FOLLOWING THEIR CONTRALATERAL SHOULDER REPLACEMENT ON (B)(6) 2024. AN ULTRASOUND ON (B)(6) 2024 DEMONSTRATED NO RETRACTED ROTATOR CUFF MUSCLE.
Patient problems: Pain
MAUDE report 23642305 ↗InjuryNov 10, 2025Unstable; Insufficient Device Problem Information; Unstable; Insufficient Device Problem Information
A REVISION SURGERY WAS PERFORMED DUE TO PATIENT DISSATISFACTION WITH THE OUTCOME OF THE ORIGINAL SURGERY.
Patient problems: Insufficient Information; Joint Laxity; Muscle/Tendon Damage
MAUDE report 23514003 ↗InjuryMar 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT HAD AN ANTERIOR SUBLUXATION OF THE RIGHT SHOULDER WITH FAILURE OF THE SUBSCAPULARIS REPAIR.
Patient problems: Nonunion/Delayed-union Bone Fracture; Subluxation
MAUDE report 16501092 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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