SMR System 1365.09.010Recalls & reported problems
Limacorporate SPA · SMR System - Reverse HP Liner Short Dia. 40mm · Class 2 · Implant
All models of SMR System (47)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390061254), received between Mar 12, 2026 and Apr 27, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Unstable” (3 reports).
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
- Unstable3
- Device Dislodged or Dislocated2
Patient problems
- Joint Dislocation2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2026Unstable; Device Dislodged or Dislocated
COMPLAINT SOURCE REPORTED A SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2026. PATIENT SUFFERED A DISLOCATION. INSTABILITY WAS INDICATED. PREVIOUS SURGERY PERFORMED ON (B)(6) 2025. PATIENT: MALE, 65 YEARS OLD. THE FOLLOWING COMPLAINTS WERE EXPLANTED: SMR REVERSE HP LINER SHORT (PRODUCT CODE: 1365.09.010, LOT: 2304712 - STER: (B)(4), SMR CEMENTLESS FINNED STEM (PRODUCT CODE: 1304.15.180, LOT: 2204389 - STER: (B)(4) SMR REVERSE FINNED HUMER. BODY (PRODUCT CODE:1352.15.050, LOT:2307216 - STER: (B)(4), SMR CONNECTOR SMALL R (PRODUCT CODE: 1374.15.305, LOT: 2308335 - STER: (B)(4), SMR REVERSE HP GLENOSPH. 40 MM (PRODUCT CODE: 1374.50.400, LOT: 2411197 - STER: (B)(4), CORTIC.BONE SCREW D.5 L.28 MM (PRODUCT CODE: 8432.15.028, LOT: 2315144 - STER: (B)(4), CORTIC.BONE SCREW D.5 L.28 MM (PRODUCT CODE: 8432.15.028, LOT: 2403889 - STER: (B)(4), SMR UNCEMENT. GLENOID #SMALL-R (PRODUCT CODE: 1375.20.005 , LOT: 2308818 - STER: (B)(4). EVENT OCCURRED IN CANADA.
Patient problems: Joint Dislocation
MAUDE report 24995510 ↗InjuryMar 13, 2026Unstable; Device Dislodged or Dislocated
REVISION SURGERY PERFORMED ON (B)(6) 2024 DUE TO INSTABILITY. THE FOLLOWING DEVICES WERE REMOVED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE: 1304.15.170, LOT: 2415046 - STER: (B)(4), SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE: 1352.15.005, LOT: 2424342 - STER: (B)(4), SMR REVERSE HP LINER SHORT (PRODUCT CODE: 1365.09.010, LOT: UNKNOWN) , THE DEVICES FINNED STEM (CODE: 1304.15.170), REVERSE LATERALIZING LINER 40MM LONG (CODE: 1365.09.120) AND SHORT REVERSE HUMERAL BODY (CODE: 1352.15.005) WERE IMPLANTED. PREVIOUS REVISION SURGERY WAS PERFORMED (B)(6) 2024. PATIENT: MALE, 82 YEARS OLD.
Patient problems: Joint Dislocation
MAUDE report 24590262 ↗InjuryMar 12, 2026Unstable
REVISION SURGERY PERFORMED ON (B)(6) 2025, DURING WHICH SMR REVERSE HP LINER SHORT (PRODUCT CODE: 1365.09.010, LOT: 2433269 - STER: 2500001) WAS REPLACED WITH A REVERSE LATERALIZING LINER 40MM MEDIUM (PRODUCT CODE: 1365.09.115), DUE TO INSTABILITY. PREVIOUS SURGERY PERFORMED (B)(6) 2025. INFORMATION ON PATIENT: FEMAIL, 77 YEARS OLD. HOSPITAL AND SURGEON ARE UNKNOWN. EVENT OCCURRED IN UNITED KINGDOM.
Patient problems: Insufficient Information
MAUDE report 24579572 ↗
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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