SMR Shoulder Liner (REF 1365.50.811)Recalls & reported problems
Limacorporate SPA · Reverse Retentive Liner 40mm Standard · Class 2 · Implant
All models of SMR Shoulder (67)
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 08033390102964), received between Jul 2, 2025 and Jul 2, 2025 — 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
- Patient Device Interaction Problem1
Patient problems
- Medical device site infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A LARGE, UNEXPLAINED HEMATOMA. THE SURGEON SUSPECTED AN INFECTION; THEREFORE, THE WOUND WAS FLUSHED, AND THE LINER WAS SWAPPED. DURING THE PROCEDURE, THE SURGEON NOTED THAT THE IMPLANT WAS TOO LOOSE, SO THE VERSION WAS ADJUSTED, AND EXTENSIONS WERE ADDED. THE FOLLOWING SMR REVERSE FINNED HUMERAL BODY AND AN SMR REVERSE RETENTIVE LINER WERE REPLACED DURING THIS SURGERY: SMR REVERSE FINNED HUMER. BODY (PART CODE 1352.15.050, LOT NUMBER 2415343, STERILIZATION (B)(4)). SMR REVERSE LINER RETENTIVE (PART CODE 1365.50.811, LOT NUMBER 22AT145, STERILIZATION (B)(4) ). THE REVISION STEM SMR CEMENTL. REV. STEM Ø15 MM (PART CODE 1308.15.156, LOT NUMBER 1810713, STERILIZATION (B)(4)) REMAINED IN SITU. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1948. THE EVENT HAPPENED IN THE UNITED STATES.
Patient problems: Medical device site infection
MAUDE report 22381445 ↗
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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