Tornier Perform Humeral System PFX09130Recalls & reported problems
Tornier, Inc. · Fracture Stem · 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00846832092307), received between Mar 28, 2025 and Sep 28, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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 Problem1
- Fracture1
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration1
- Insufficient Information1
- Joint Dislocation1
- Malunion of Bone1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Joint Dislocation
MAUDE report 50922232 ↗MalfunctionApr 15, 2026Fracture
A REVISION SURGERY WAS PERFORMED DUE TO A BROKEN HUMERAL STEM WHICH WAS BROKEN AT THE END LEVEL OF THE SUPERIOR MOST LATERAL SCREW.
Patient problems: Insufficient Information
MAUDE report 24888828 ↗InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "SUBJECT: (B)(6)." PERFORM FRACTURE STUDY. DELAYED UNION: RADIOLOGIST NOTIFIED SPONSOR OF DELAYED NONUNION/BONE NOT YET CONSOLIDATED AT 6 MONTH X-RAY. SPONSOR SUBSEQUENTLY NOTIFIED SITE."
Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture
MAUDE report 21718723 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
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- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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