TORNIER PERFORM™ HUMERAL SYSTEM DWP2360Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00846832084456), received between Dec 22, 2023 and Jul 27, 2026 — classified as 6 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 Problem4
- Device Dislodged or Dislocated1
- Unstable1
Patient problems
- Pain3
- Bone Fracture(s)1
- Joint Dislocation1
- Joint Laxity1
- Post Operative Wound Infection1
- Unspecified Infection1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
All implants were removed due to suspected infection.
Patient problems: Post Operative Wound Infection
MAUDE report 50042216 ↗InjuryMar 19, 2026Unstable
IT WAS REPORTED THAT, THE PRIMARY SURGERY WAS CONDUCTED ON (B)(6) 2025. LATER, HE FELT LOOSENESS IN HIS SHOULDER JOINT WHEN GOING TO BED. PARTIAL REVISION ARTHROPLASTY WAS CONDUCTED ON (B)(6) 2026 DUE TO INSTABILITY, ALTHOUGH NO DISLOCATION WAS PRESENT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Joint Laxity
MAUDE report 24640671 ↗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 23642355 ↗InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD INFECTION AFTER SHOULDER REPLACEMENT SURGERY. PAIN WAS ALSO REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Pain; Unspecified Infection
MAUDE report 22794920 ↗InjuryFeb 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT IS HAVING BILATERAL INCISION PAIN. THERE ARE NO HARDWARE COMPLICATIONS. X-RAYS AT 12 MONTHS CONFIRMED NO HARDWARE COMPLICATION. PLAN TO WORK UP FOR INFLAMMATORY ISSUES, REFERRAL TO RHEUMATOLOGY, PAIN CLINIC AND MRI OF CERVICAL SPINE TO RULE OUT RADICULOPATHY.
Patient problems: Pain
MAUDE report 18681615 ↗InjuryDec 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
AS REPORTED: "THE PATIENT RE-DISLOCATED ON (B)(6) 2023 AND 2ND REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THE DISLOCATION HAVE OCCURRED WHILE THE PATIENT WAS SLEEPING IN THE HOSPITAL, AND THE CAUSE OF THE DISLOCATION WAS COMPLETELY UNKNOWN TO THE DOCTORS."
Patient problems: Joint Dislocation
MAUDE report 18387214 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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