SMR Shoulder 1365.54.820Recalls & reported problems
Limacorporate SPA · SMR Shoulder - Reverse Liner +6 mm Dia. 40 mm - LIMAVIT · 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 08033390204576), received between Feb 19, 2025 and Feb 19, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
Patient problems
- Joint Dislocation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO DISLOCATION. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2024 AND DURING THIS SURGERY THE FOLLOWING COMPONENT WERE IMPLANTED: SMR FINNED STEM SHORT D.18 (PART CODE 1304.15.018, LOT NUMBER 2424861, STERILIZATION (B)(4)). SMR REVERSE HUMERAL BODY (PART CODE 1352.15.010, LOT NUMBER 2424902, STERILIZATION (B)(4)). REVERSE LINER +6 MM D.40 MM (PART CODE 1365.54.820, LOT NUMBER 23AT3Z4, STERILIZATION (B)(4)). CONNECTOR W. SCREW HIGH LAT.9MM (PART CODE 1974.15.304, LOT NUMBER 2417922, STERILIZATION (B)(4)). BASEPLATE D.25MM FULL WEDGE10° (PART CODE 1975.14.510, LOT NUMBER 2413702, STERILIZATION (B)(4)). GLENOSPH.ECC. D.40MM ECC.4MM (PART CODE 1976.09.040, LOT NUMBER 2410437, STERILIZATION (B)(4)). DURING THE REVISION SURGERY THE REVERSE LINER +6 MM D.40 MM PREVIOUSLY IMPLANTED WAS REMOVED AND REPLACED BY THE FOLLOWING NEW COMPONENTS: EXTENSION FOR HUMERAL REVERSE BODY (PART CODE 1352.15.001, LOT NUMBER 2416707, STERILIZATION (B)(4)). SMR REVERSE LINER RETENTIVE +3MM DIA=40MM (PART CODE 1365.54.816, LOT NUMBER 23AT3V4, STERILIZATION (B)(4)). THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1944. THE EVENT HAPPENED IN THE UNITED STATES.
Patient problems: Joint Dislocation
MAUDE report 21415269 ↗
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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