Shoulder Prosthesis, Reverse Configuration
FDA adverse event reports and recall history for shoulder prosthesis, reverse configuration (product code PHX), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 12,771
- Deaths
- 11
- Injuries
- 11,323
- Malfunctions
- 1,437
Reports per year
Source: FDA adverse event reports by year received, 2015–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-08-19Open, ClassifiedDevice Design
Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product Product Description: The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse shoulder replacement for patients with a functional deltoid muscle and with a deficient rotator cuff. The restor3d Reverse Total Shoulder Arthroplasty System consists of the glenoid baseplate, glenosphere intraoperatively affixed to the baseplate, humeral stem, and polymer bearing component affixed to the humeral stem. Additionally, the system includes supporting standard instrument trays and all required accessories (e.g., security screws, peripheral screws). The restor3d rTSA System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The Veritas standard glenoid baseplate is the only component within scope of this field action. The patient-specific baseplate is unaffected by this defect and therefore not in scope. Component: Reverse Total Shoulder
Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
- 2026-06-29Open, ClassifiedDevice Design
Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.0975, 13/04.01.10.0976, 14/04.01.10.0977, 15/04.01.10.0978, 16/04.01.10.0979 Part of Medacta Shoulder System
Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus.
- 2026-06-23Open, ClassifiedUnder Investigation by firm
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- 2026-06-23Open, ClassifiedUnder Investigation by firm
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- 2026-06-23Open, ClassifiedUnder Investigation by firm
Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- 2026-06-23Open, ClassifiedUnder Investigation by firm
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- 2026-06-23Open, ClassifiedUnder Investigation by firm
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- 2026-02-24Open, ClassifiedProcess control
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Knee and Humeral socket implants contain incorrect labeling.
- 2025-11-17Open, ClassifiedRelease of Material/Component prior to receiving test results
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
- 2025-11-17Open, ClassifiedRelease of Material/Component prior to receiving test results
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
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