PERFORM™ HUMERAL SYSTEM DWP1390Recalls & reported problems
Tornier, Inc. · Class 2 · Implant
All models of PERFORM HUMERAL SYSTEM (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832077304), received between May 6, 2021 and Jan 8, 2025 — classified as 2 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 Problem1
- Device Dislodged or Dislocated1
Patient problems
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER SURGERY REQUIRING REVISION DUE TO UNKNOWN REASONS.
Patient problems: Insufficient Information
MAUDE report 21107390 ↗InjuryMay 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON THE SHOULDER. APPROXIMATELY 2 MONTHS POST-OP DURING A FOLLOW UP APPOINTMENT, IT WAS FOUND THAT THE SHOULDER HAD DISLOCATED. THE SURGEON PERFORMED A CLOSED REDUCTION; HOWEVER, THE SURGEON DID NOT FEEL THE JOINT WAS STABLE. THE SURGEON OPENED UP THE SHOULDER AND FOUND THE POLY HAD SIGNIFICANT MEDIAL WEAR. THE SURGEON REMOVED THE POLY AND INSERTED A THICKER RETENTIVE POLY TO STABILIZE THE JOINT. PHYSICIAN NOTED THAT THIS PATIENT HAS HISTORICALLY BEEN NON-COMPLIANT WITH HIS INSTRUCTIONS AND THOUGHT THAT COULD HAVE CONTRIBUTED TO OUTCOME.
Patient problems: Failure of Implant
MAUDE report 11786632 ↗
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 16, 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