SMR System 1308.15.154Recalls & reported problems
Limacorporate SPA · SMR System - Revision Stem Dia. 15 mm H. 150 mm · Class 2 · Implant
All models of SMR System (47)
Data updated Oct 16, 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 08033390271646), received between Nov 20, 2025 and Nov 20, 2025 — classified as 1 injury.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE COMPLAINT SOURCE REPORTED REVISION SURGERY PERFORMED ON (B)(6) 2025, WITH REMOVAL OF THE SMR CEMENTLESS STEM Ø15 MM, TOGETHER WITH THE GLENOSPHERE, LINER, AND HUMERAL BODY. THE REASON FOR THE REMOVAL OF THE STEM WAS THE NECESSITY TO IMPLANT A CUSTOM-MADE DEVICE (B)(4)). THE STANDARD DEVICE EXPLANTED ON (B)(6) 2025 - LISTED BELOW- WERE IMPLANTED ON (B)(6) 2023 TOGETHER WITH THE CUSTOM MADE (B)(4), WHICH WAS NECESSARY TO TREAT THE SHOULDER JOINT, GLENOID SIDE: · SMR CEMENTL. REV. STEM Ø15 MM (PRODUCT CODE:1308.15.154 - LOT:1517468) · SMR REVERSE FINNED HUMER. BODY (PRODUCT CODE: 1352.15.050, - LOT: 2305345- STER: (B)(4)) · SMR REVERSE HP LINER SHORT (PRODUCT CODE: 1362.09.010 - LOT:2119266) · SMR REVERSE HP GLENOSPH. 44 MM (PRODUCT CODE: 1374.50.440, LOT: 2108544 - STER: (B)(4)) ON THE SAME SIDE, THE PATIENT HAD AN ELBOW PROSTHESIS ALREADY IMPLANTED. SUCCESSIVELY, A CUSTOM-MADE DEVICE FOR ELBOW (B)(4) WAS DEEMED NECESSARY DUE TO "TRAUMATIC INJURY, RADIAL NERVE DAMAGE ON THE RIGHT SIDE AFTER HUMERAL FRACTURE, MISSING ELBOW AFTER ACCIDENT/INFECTION. SMR CEMENTLESS REVISION STEM SIZE Ø15MM H.150MM IN SITU." THE DEVELOPMENT OF (B)(4) BECAME NECESSARY BECAUSE THE SMR CEMENTLESS STEM Ø
Patient problems: Insufficient Information
MAUDE report 23605996 ↗
Other Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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