SMR Shoulder 1374.09.131Recalls & reported problems
Limacorporate SPA · SMR Shoulder - Glenosphere Dia. 42 mm · 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 08033390204538), received between Nov 10, 2025 and Nov 10, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Unstable” (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
- Unstable1
Patient problems
- Joint Laxity1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2025Unstable; Unstable
REVISION SURGERY DUE TO INSTABILITY PERFORMED ON (B)(6) 2025. PATIENT UNDERWENT SURGERY FOR A REVERSE SHOULDER ON (B)(6) 2025, IN WHICH THE FOLLOWING COMPONENTS WERE IMPLANTED: - SHORT STEM PLUS #5 (PART CODE 1357.14.236, LOT NUMBER 2413552, STERILIZATION (B)(4)) - PRIMA REVERSE TRAY #SHORT (PART CODE 1367.15.010, LOT NUMBER 2434587, STERILIZATION (B)(4)) - PRIMA REV.INSERT #SHORT D.42MM (PART CODE 1367.54.300, LOT NUMBER 2122627, STERILIZATION (B)(4)) - SMR GLENOSPHERE Ø 42MM (PART CODE 1374.09.131, LOT NUMBER 2123235, STERILIZATION (B)(4)) - SMR SMALL-R CONNECTOR +4 (PART CODE 1374.15.314, LOT NUMBER 2101336, STERILIZATION (B)(4)) - SMR METAL-BACK GLENOID SMALL R (PART CODE 1375.21.005, LOT NUMBER 2402374, STERILIZATION (B)(4)) THUMB TEST WAS DONE ON HUMERAL CUT SURFACE PRIOR TO IMPLANTATION OF PRIMA STEM. DUE TO THE SIZE OF THE PATIENT, THE SURGEON DETERMINED THE NECESSITY OF THIS IMPLANT TO ACHIEVE DESIRED MEDIALIZATION OF THE HUMERUS AND LATERALIZATION OF THE GLENOID COMPONENTS. THEREFORE, DURING THE REVISION HEREBY REPORTED, THE GLENOSPHERE AND THE LATERALIZED CONNECTOR WERE REMOVED AND REPLACED BY THE FOLLOWING COMPONENTS: - SMR GLENOSPHERE Ø 40MM (PART CODE 1374.09.121, LOT
Patient problems: Joint Laxity
MAUDE report 23511053 ↗
Other Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer devices
- R3 71363077Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER461 reports
- NA 71364009Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER174 reports
- JOURNEY 74012416Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74012415Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74012414Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER129 reports
- GENESIS II 71440194Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER114 reports
- GENESIS II 71440842Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER113 reports
- JOURNEY 74018901Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER106 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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