SMR Shoulder 1352.15.051 (UDI 08033390156974)Recalls & reported problems
Limacorporate SPA · SMR Shoulder - Humeral Body 140° Finned Reverse · Class 2 · Implant
All models of SMR Shoulder (67)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390156974), received between Nov 24, 2025 and Nov 24, 2025 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Joint Dislocation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO DISLOCATION. NON-COMPLIANT PATIENT WITH MENTAL HEALTH ISSUES DISLOCATED HIS SHOULDER BUT DOESN'T KNOW HOW OR WHEN, RESULTING IN POLY LINER SWAP. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED WITH NEW PARTS: FINNED REVERSE HUMERAL BODY 140° (PART NUMBER: 1352.15.051, LOT NUMBER: 2014680, STERILIZATION: 2100020). SMR REVERSE LINER +6MM D 40MM (PART NUMBER: 1365.50.820, LOT NUMBER: 23AT489, STERILIZATION: 2400196). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025. THE PATIENT IS MALE, DATE OF BIRTH ON (B)(6) 1947. THE EVENT OCCURRED IN THE UNITED STATES.
Patient problems: Joint Dislocation
MAUDE report 23630533 ↗
Other Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented devices
- COMPREHENSIVE SHOULDER SYSTEM 113629Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall2 reports
- COMPREHENSIVE SHOULDER SYSTEM 113617Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall1 report
- Comprehensive® Shoulder System 113607Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall1 report
- BIO-MODULAR SHOULDER SYSTEM 113865Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COPELAND SHOULDER SYSTEM 11-114648Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COMPRESS DEVICE 178787Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- BIO-MODULAR SHOULDER SYSTEM 113863Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- BIO-MODULAR SHOULDER SYSTEM 113867Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 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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