SMR Shoulder Glenosphere (REF 1374.09.120)Recalls & reported problems
Limacorporate SPA · Glenosphere · 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 08033390102995), received between Oct 27, 2025 and Oct 27, 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 16, 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.
InjuryOct 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO CHRONIC DISLOCATION. THE REVERSE IMPLANT WAS REPLACED BY HEMI. DATE OF PREVIOUS SURGERY IS UNKNOWN. THE FOLLOWING COMPONENTS WERE REMOVED: - SMR HUMERAL EXTENSION + 9 MM (PART CODE 1352.15.001, LOT NUMBER 2313276, STERILIZATION (B)(4)). - SMR REVERSE LINER RETENTIVE (PART CODE 1365.50.821, LOT NUMBER 23AT3BW, STERILIZATION (B)(4)). - SMR GLENOSPHERE Ø40MM (PART CODE 1374.09.120, LOT NUMBER 1506088, STERILIZATION (B)(4)). - SMR METAL-BACK GLENOID STD (PART CODE 1375.21.010, LOT NUMBER 1617881, STERILIZATION (B)(4)). THE ABOVE-MENTIONED DEVICES WERE REPLACED BY THE FOLLOWING NEW ONES: - SMR ADAPTOR FOR REVERSE BODY (PART CODE 1352.15.200, LOT NUMBER 2410001, STERILIZATION (B)(4)). - SMR EXTENSION FOR REVERSE HUMERAL BODY (PART CODE 1352.15.001, LOT NUMBER 2515817, STERILIZATION (B)(4)). - SMR CTA HEAD (PART CODE 1323.09.460, LOT NUMBER 2517496, 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 23390078 ↗
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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