TORNIER PERFORM™ HUMERAL SYSTEM MWX135Recalls & reported problems
Tornier, Inc. · Class 2
All models of TORNIER PERFORM HUMERAL SYSTEM (68)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832082377), received between Jan 6, 2026 and Apr 7, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Erosion” (2 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
- Material Erosion2
- Material Deformation1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2026Material Erosion
IT WAS REPORTED THAT, WHEN INSERTING THE GUIDE PIN (3X75 MM) INTO THE IM CUTTING BLOCK 135° (MWX135), METAL ABRASION OCCURRED ON THE GUIDE PIN AT THE UPPER 0° HOLE FOR THE GUIDE PINS FOR RESECTION OF THE RIGHT SHOULDER. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24801419 ↗InjuryJan 6, 2026Material Erosion; Material Deformation
IT WAS REPORTED THAT, REPEATEDLY, THE INSERTION OF THE GUIDE WIRE INTO THE MWX135 ¿ IM CUTTING BLOCK, 135°, HAS RESULTED IN METAL ABRASION AT ONE OF THE GUIDE-WIRE ENTRY HOLES. METAL PARTICLES HAD TO BE REMOVED MANUALLY FROM THE SURGICAL SITE. METAL PARTICLES MAY REMAIN IN THE SURGICAL SITE, POSING AN INFECTION RISK DUE TO FOREIGN MATERIAL."
Patient problems: Foreign Body In Patient
MAUDE report 23975788 ↗
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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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