SMR System 1352.15.001Recalls & reported problems
Limacorporate SPA · SMR System - Extension for Humeral Reverse Body · Class 2 · Implant
All models of SMR System (47)
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 08033390272513), received between Jan 2, 2026 and Jan 2, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 other recall cover devices cleared under the same FDA submission (K110598); they may or may not involve this specific model.
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
- Detachment of Device or Device Component1
Patient problems
- Loose body in joint1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 2, 2026Detachment of Device or Device Component
REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO DISASSEMBLY OF COMPONENTS IN SHOULDER PROSTHESIS. THE EXTENSION FOR HUMERAL BODY (PART NUMBER 1352.15.001, LOT UNKNOWN) DISASSOCIATED FROM THE HUMERAL BODY, THEREFORE SURGEON REPLACED IT WITH A NEW SPACER (PART NUMBER 1352.15.001) AND RENEWED THE RETENTIVE LINER +6MM (PART NUMBER 1361.50.820) FOR COMPATIBILITY REASONS, EVEN THOUGH NO ISSUE WAS REPORTED ON THE LINER. SURGERY HAS COMPLETED AS INTENDED. PREVIOUS SURGERY DATE IS UNKNOWN, AS WELL AS ALL THE PREVIOUSLY IMPLANTED COMPONENTS. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1951. THE EVENT OCCURRED IN THE UNITED STATES.
Patient problems: Loose body in joint
MAUDE report 23944385 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K110598. One submission often covers many models, so check the product and lot details in each record.
- Z-1711-2016 · Apr 8, 2016 · TerminatedSMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
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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