SMR System 1304.15.110Recalls & reported problems
Limacorporate SPA · SMR System - Finned Stem Dia. 11 mm L. 60 mm · Class 2 · Implant
All models of SMR System (47)
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 08033390270694), received between May 29, 2025 and May 29, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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
- Failure to Osseointegrate1
- Patient Device Interaction Problem1
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2025Failure to Osseointegrate; Patient Device Interaction Problem; Failure to Osseointegrate; Patient Device Interaction Problem
SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO LOOSENING OF THE SMR CEMENTLESS MINI STEM (PRODUCT CODE: 1304.15.110, LOT#: 2408106 - STER. 2400113). ACCORDING TO THE RECEIVED INFORMATION, THE STEM DID NOT HAVE GOOD FIXATION PROXIMALLY, MORE THAN LIKELY AS A RESULT OF THE PRIMARY IMPLANT THAT WAS DUE TO A FRACTURE. IT WAS ALSO REPORTED THAT THE PATIENT PRESENTED OF COMPLAINING OF PAIN, AND X-RAYS SHOWED WHAT APPEARED TO BE BONE RESORPTION AND IT WAS DETERMINED THAT THE STEM WAS LOOSE. THE STEM ALONG WITH ALL OTHER STEM-RELATED PARTS WERE EXTRACTED, IN DETAILS: SMR CEMENTLESS MINI STEM (PRODUCT CODE: 1304.15.110, LOT#: 2408106 - STER. 2400113). SMR HUMERAL EXTENSION + 9 MM (PRODUCT CODE: 1352.15.001, LOT#: 2416019 - STER. 2400149). SMR REVERSE FINNED HUMERAL BODY (PRODUCT CODE: 135215050, LOT#: 2009741 - STER. 2000208). SMR REVERSE LINER + 3 MM (PRODUCT CODE: 136050815, LOT#: 23AT248 - STER. 2300197). THE DOCTOR THEN IMPLANTED COMPETITOR'S HUMERAL DEVICES. PREVIOUS SURGERY ON (B)(6) 2024. PATIENT IS A FEMALE, 60 YEARS OLD. NO OTHER CLINICAL DATA ARE AVAILABLE. EVENT HAPPENED IN THE US.
Patient problems: Implant Pain
MAUDE report 22104980 ↗
Other Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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