PERFORM™ HUMERAL SYSTEM DWS2360Recalls & 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 00846832078059), received between May 22, 2025 and Oct 15, 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
- Joint Dislocation2
- Limb Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 23300189 ↗InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A REVISION SURGERY WAS PLANNED USING THE BLUEPRINT PLANNING FEATURE. THIS WAS A REVISION SURGERY WITH TORNIER IMPLANTS, THE PATIENT WAS UNSTABLE AFTER THE ORIGINAL SURGERY. THE PATIENT IS A 76 YO FEMALE WHO SUFFERED A PROXIMAL HUMERUS FRACTURE WHERE THE SURGEON ORIGINALLY TREATED USING OUR PERFORM FRACTURE STEM. ON THE REVISION CASE THE SURGEON REMOVED THE ORIGINAL 36 MM STANDARD GLENOSPHERE AND 36 3/4 VITAMIN E 0MM POLY LINER. HE REPLACED THE SPHERE AND POLY WITH A 39 MM STANDARD GLENOSPHERE AND 39 3/4 0MM VE POLY FOR STABILITY. THE SURGERY WAS A SUCCESS AND THE PATIENT WAS REDUCED WITHOUT ANY FURTHER INSTABILITY ISSUES DUE TO UPSIZE IN THE SPHERE.
Patient problems: Joint Dislocation; Limb Fracture
MAUDE report 22074124 ↗
Other prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented devices
- Comprehensive Reverse Shoulder 115310Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death99 reports
- INHANCE 5120-00-110Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented75 reports
- Comprehensive® Reverse Shoulder XL-115364Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall7 reports
- Comprehensive® Reverse Shoulder XL-115366Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall4 reports
- Comprehensive® Reverse Shoulder 180550Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 deaths43 reports
- DJO SURGICAL 521-07-246Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- Comprehensive® Reverse Shoulder 180551Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- Comprehensive® 110031399Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death36 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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