SMR System 1362.09.120Recalls & reported problems
Limacorporate SPA · SMR System - Reverse HP Lateralizing Liner Long Dia. 44mm · Class 2 · Implant
All models of SMR System (47)
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 08033390050036), received between Sep 23, 2026 and Sep 23, 2026 — 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
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Unstable
A revision surgery was performed on (b)(6) 2025 due to implant instability. The surgical approach was restricted in terms of lateralisation on the glenoid side due to the monoblock design of the custom glenoid. Different humeral options were trialled to achieve stability. The surgeon felt that the extension and long lateralised liner were providing excessive length without corresponding lateralisation, potentially contributing to instability. The extension and long lateralised liner were therefore removed and replaced with a long lateralised liner.Previous surgery was performed on (b)(6) 2025. The CMD 25-1154 implant (CMD 25-1154 Monoblock Glenoid, product code 9617.PE.04Z), which had been implanted on (b)(6) 2025, was not revised, together with the humeral body and the stem.The surgeon followed the standard surgical workflow for shoulder revision. The explanted components included:SMR HUMERAL EXTENSION + 9 MM (Product code 1352.15.001, lot 2422607, ster. n. 2400222).SMR REVERSE HP LAT. LINER LONG (Product code 1362.09.120, lot 2422590, ster. n. 2400215).Patient is Male, 81 years old.Event happened in Australia.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50865350 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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