SMR TT Augmented 360 1375.15.569Recalls & reported problems
Limacorporate SPA · SMR TT Augmented 360 Baseplate S-R 19°X · Class 2 · Implant
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 08033390180047), received between May 27, 2026 and May 27, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Patient Device Interaction Problem1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
A SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2026. THE METAL BACK TT AUG.360 BASEPLATE #S-R 19°X (PRODUCT CODE: 1375.15.569 - LOT: UNKNOWN) BECOME LOOSE DUE TO A FRACTURE OF THE GLENOID. THE LIST OF DEVICES INVOLVED DURING REVISION: TT AUG.360 BASEPLATE #S-R 19°X (PRODUCT CODE: 1375.15.569 - LOT: UNKNOWN) - SOLD IN US, SMR GLENOID PEG TT SMALL-R #M (PRODUCT CODE: 1375.14.652 - LOT: UNKNOWN) - SOLD IN US, BONE SCREW Ø6,5 H.20MM (PRODUCT CODE: 8420.15.010 - LOT: UNKNOWN) - SOLD IN US, BONE SCREW Ø6,5 H.25MM (PRODUCT CODE: 8420.15.020 - LOT: UNKNOWN) - SOLD IN US. EVENT OCCURRED IN AUSTRIA.
Patient problems: Bone Fracture(s)
MAUDE report 25297975 ↗
Other Shoulder Prosthesis, Reverse Configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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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