SMR System 1375.14.652Recalls & reported problems
Limacorporate SPA · SMR System - Glenoid Peg TT Small-R Medium · 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 08033390270540), received between Jan 28, 2026 and Jan 28, 2026 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate1
- Patient Device Interaction Problem1
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.
InjuryJan 28, 2026Failure to Osseointegrate; Patient Device Interaction Problem
REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO BASEPLATE FAILURE. REPORTEDLY, THE TT PEG FAILED TO OSSEOINTEGRATE. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL IMPLANT. DURING REVISION, THE SURGEON REMOVED THE LOOSENED PRE-EXISTING GLENOID COMPONENTS: SMR GLENOID BASEPLATE SMALL-R (PART NUMBER 1375.15.605), SMR GLENOID PEG TT SMALL-R #M (PART NUMBER 1375.14.652), TWO BONE SCREWS Ø6,5 H.25MM (PART NUMBER 8420.15.020), SMR GLENOSPHERE Ø 36MM (PART NUMBER 1374.09.111), SMR SMALL-R CONNECTOR +4 (PART NUMBER 1374.15.314), AND CONVERTED THE REVERSE HUMERAL ASSEMBLY TO AN ANATOMIC HEMIARTHROPLASTY USING ADAPTOR 36MM FOR REVERSE BODY (PART NUMBER 1352.15.200) AND CTA HEAD DIA46 (PART NUMBER 1323.09.460). SURGERY HAS BEEN COMPLETED AS INTENDED. THE PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1958. THE EVENT OCCURRED IN THE UNITED STATES.
Patient problems: Joint Laxity
MAUDE report 24197899 ↗
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- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
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- 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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