SMR System 1304.15.170Recalls & reported problems
Limacorporate SPA · SMR System - Finned Stem Dia. 17 mm L. 80 mm · Class 2 · Implant
All models of SMR System (47)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390270809), received between May 2, 2017 and Jun 6, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
- Device Contamination with Chemical or Other Material1
- Device Dislodged or Dislocated1
- Scratched Material1
Patient problems
- Joint Dislocation1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO SUBSIDENCE AND DISLOCATION. THE PATIENT UNDERWENT AN INITIAL TRAUMA SURGERY (PROXIMAL HUMERUS FRACTURE) ON (B)(6) 2025. AFTER ANOTHER REVISION SURGERY (PERFORMED ON (B)(6) 2025 AND TRACKED AS COMPLAINT (B)(4)) THE STEM SUBSIDED, AND PATIENT KEPT DISLOCATING. BEFORE THE REVISION PERFORMED ON (B)(6) 2025 (HEREBY REPORTED), THE PATIENT HAD THE FOLLOWING IMPLANTED DEVICES: - SMR REVERSE LINER RETENTIVE (PART CODE 1365.50.821, LOT NUMBER 24AT0Y0, STERILIZATION (B)(4)). - SMR CEMENTLESS FINNED STEM (PART CODE 1304.15.170, LOT NUMBER 2427770, STERILIZATION (B)(4)). - SMR REVERSE FINNED HUMER. BODY (PART CODE 1352.15.050, LOT NUMBER 2310073, STERILIZATION (B)(4)). - SMR SMALL/STD CONNECTOR +2 (PART CODE1374.15.322, LOT NUMBER 2427413, STERILIZATION (B)(4)). - SMR ECCENT. GLENOSPHERE DIA. 40MM (PART CODE 1376.09.041, LOT NUMBER 2433701, STERILIZATION (B)(4)). DURING THE REVISION HEREBY REPORTED THE DEVICES PREVIOUSLY IMPLANTED WERE REPLACED BY THE FOLLOWING ONES: - SMR ECC. GLENOSPHERE DIA. 40MM (PART CODE 1376.09.041, LOT 2501637, STERILIZATION (B)(4)). - SMR SMALL/STD CONNECTOR +4 + SCREW (PART CODE 1374.15.324. LOT 2325957, STERILIZATION
Patient problems: Joint Dislocation
MAUDE report 22159156 ↗MalfunctionMay 2, 2017Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Scratched Material
PACKAGING ISSUE INVOLVING A SMR CEMENTLESS FINNED STEM, MODEL# 1304.15.170, LOT# 1520757. WHEN OPENING THE PACKAGE CONTAINING THE STEM, SOME SCRATCHES HAVE BEEN NOTICED ON THE INNER POUCH AND ALSO WHITE POWDER WAS OBSERVED ON THE SURFACE OF THE STEM. ACCORDING TO THE INFO REPORTED, THE POWDER WAS COMPLETELY REMOVED BY THE NURSE USING STERILE WATER AND, AFTER THIS STEP, THE STEM WAS IMPLANTED. NO HEALTH DAMAGE FOR THE PATIENT REPORTED. EVENT HAPPENED IN (B)(6).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6536428 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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