TORNIER PERFORM™ HUMERAL SYSTEM DWP2363Recalls & 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 00846832084463), received between May 30, 2023 and Sep 28, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).
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
- Device Dislodged or Dislocated3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Joint Dislocation3
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation
MAUDE report 50922228 ↗InjuryDec 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
DISLOCATION REVISION SURGERY WILL BE PLANED ON (B)(6).
Patient problems: Joint Dislocation
MAUDE report 20842751 ↗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 18680610 ↗InjuryMay 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE INLAY LUXATION RADIOLOGICALLY VISIBLE ON THE FIRST DAY AFTER SURGERY. DURING MEDICAL PROCEDURE REGULAR INSERTION OF THE INLAY WAS PERFORMED. THE PATIENT UNDERWENT A REVISION SURGERY.
Patient problems: Joint Dislocation
MAUDE report 17019098 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page