SMR System 1375.14.653Recalls & reported problems
Limacorporate SPA · SMR System - Glenoid Peg TT Small-R Long · 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 08033390270557), received between Apr 18, 2023 and Apr 18, 2023 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Patient Device Interaction 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.
InjuryApr 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
SHOULDER REVISION SURGERY DUE TO LOOSENING OF THE BASEPLATE SMR GLENOID BASEPLATE SMALL-R, CODE 137515650, LOT 1514020.(THIS PRODUCT CODE IS NOT CLEARED IN THE USA, BUT IT WAS USED IN COMBINATION WITH THE PEG WITH CODE 1375.14.653, LOT 1515025). THE REVISION SURGERY DATE IS (B)(6) 2018, THE ORIGINAL SURGERY TOOK PLACE IN TWO STAGES (B)(6) 2016 AND (B)(6) 2016). ACCORDING TO THE COMPLAINT SOURCE, THE BASEPLATE HAD DETACHED FROM THE BONE TOGETHER WITH THE SCREW AND THE GLENOSPHERE. PATIENT DATA: MALE, BORN IN 1957, HEIGHT 162 CM, WEIGHT 52KG, SMOKING. THIS EVENT OCCURRED IN THE UK.
Patient problems: Insufficient Information
MAUDE report 16761155 ↗
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- 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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