Prosthesis, Shoulder, Semi-constrained, Metal/polymer + Additive, Cemented
Orthopedic · 21 CFR 888.3660
Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.
Recent MDR events
755 adverse event reports on file
- PERFORM 55% INSERT VE SZ1/2 36 MM +3Jul 28, 2026InjuryTornier Inc0001649390-2026-00773
- UNKNOWN TORNIER PERFORM IMPLANTJul 22, 2026InjuryTornier Inc0001649390-2026-00731
- UNKNOWN TORNIER PERFORM IMPLANTJul 22, 2026InjuryTornier Inc0001649390-2026-00734
- UNKNOWN TORNIER PERFORM IMPLANTJul 22, 2026InjuryTornier Inc0001649390-2026-00733
- UNKNOWN TORNIER PERFORM IMPLANTJul 22, 2026InjuryTornier Inc0001649390-2026-00735
- UNKNOWN TORNIER PERFORM IMPLANTJul 22, 2026InjuryTornier Inc0001649390-2026-00732
- INHANCEJul 20, 2026InjuryDepuy Ireland - 30155162661818910-2026-12257
- DJO SURGICALJul 6, 2026InjuryEncore Medical L.p.1644408-2026-01289
- DJO SURGICALJul 6, 2026InjuryEncore Medical L.p.1644408-2026-01297
- UNKNOWN TORNIER PERFORM STEMJun 30, 2026InjuryTornier Inc0001649390-2026-00685
Event type breakdown
Recalls
3 recall events for this product code
- Tornier, IncOpen, ClassifiedSep 27, 2024
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.
Z-3309-2024 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedFeb 11, 2017
Comprehensive Reverse Shoulder System Humeral Tray
Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.
Z-1103-2017 · View FDA record ↗ - Biomet, Inc.TerminatedJun 17, 2013
Superior Approach Resection Guide Assembly.
Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin that is intended to hold the guide into place may not come into contact with the bone.
Z-1548-2013 · View FDA record ↗
Registered firms
207 firms currently registered for this product code
Depuy Orthopaedics, Inc.
WARSAW, IN, US
Avalign Delivery Systems Division
Greenwood, IN, US
Micropulse Inc
Columbia City, IN, US
Bbf Sterilisationsservice Gmbh
Kernen Baden-Wurttemberg, DE
Biomet, Inc.
WARSAW, IN, US
Isomedix Operations, Inc.
Libertyville, IL, US
Ortho Solutions Sdn Bhd
Prai, Penang Pulau Pinang, MY
Zimmer, Inc.
WARSAW, IN, US
Encore Medical, L.p.
AUSTIN, TX, US
Zimmer Biomet Taiwan Co., Ltd.
Taipei, TW
Lsm-med S.r.l.
Serravalle San Marino Citta, SM
Limacorporate S.p.a.
Calatafimi Segesta (TP) Sicilia, IT
Lynx Medical Nj
Franklin, NJ, US
Turnco Tool & Instrument, Inc.
Georgetown, TX, US
Straits Orthopaedics (mfg) Sdn Bhd
Bandar Cassia Pulau Pinang, MY
Depuy Ireland Uc
Co. Cork Munster, IE
Sterigenics Us, Llc
Lewis Center, OH, US
Paragon Medical Inc.
Smithfield, UT, US
Orthoplastics Ltd
Bacup Lancashire, GB
Zimmer Biomet Korea Ltd.
Seoul, KR
510(k) clearances
1 clearances for this product code