SMR Shoulder Finned Stem (REF 1304.15.150)Recalls & reported problems
Limacorporate SPA · Finned humeral stems - 80mm (Ti6Al4V) dia.15mm · Class 2 · Implant
- 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 08033390000895), received between Sep 17, 2024 and Sep 17, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Inadequate Osseointegration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
SHOULDER REVISION SURGERY OF A SMR REVERSE SYSTEM PERFORMED ON (B)(6) 2024, DUE TO LOOSENING OF THE SMR CEMENTLESS FINNED STEM Ø15 (PRODUCT CODE 1304.15.150, LOT #1005420 - STER. (B)(6)). DURING SURGERY, ALL HUMERAL IMPLANTS GOT REMOVED: · SMR CEMENTLESS FINNED STEM Ø15 (PRODUCT CODE 1304.15.150, LOT #1005420 - STER. (B)(6)). · SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #1614599 - STER. (B)(6)). · SMR REVERSE HP LINER MEDIUM (PRODUCT CODE 1362.09.015, LOT #1514018 - STER. (B)(6)). - PRODUCT NOT SOLD IN THE US A LONG 13X150 CEMENTED HUMERAL STEM WAS IMPLANTED WITH A SHORT BODY AND A LONG LATERALIZING LINER. IT WAS REPORTED THAT THE STEM WAS DOWNSIZED FROM DIA. 15MM TO DIA. 13MM, AND THE LINER CHANGED FROM HP MEDIUM TO LATERALIZING LONG TO ACHIEVE STABILITY. PATIENT IS A FEMALE (OTHER CLINICAL INFORMATION WASN'T ACCESSIBLE). THE HISTORY OF SHOULDER SURGERIES IS THE FOLLOWING: - PRIMARY SURGERY ON (B)(6) 2011: THE SMR REVERSE SYSTEM WAS IMPLANTED; - 1ST REVISION SURGERY ON (B)(6) 2015, DUE TO PAIN AND JOINT STIFFNESS. THE EVENT WAS REGISTERED AS COMPLAINT (B)(4). THE HUMERAL BODY AND THE REVERSE LINER WERE REPLACED; - 2ND REVISION SURGERY ON (B)(6) 2017, DUE TO PAIN
Patient problems: Inadequate Osseointegration
MAUDE report 20234678 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.