SMR Shoulder 1360.54.810Recalls & reported problems
Limacorporate SPA · SMR Shoulder - Reverse Liner STD Dia. 36 mm · Class 2 · Implant
All models of SMR Shoulder (67)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390268134), received between May 26, 2026 and Jun 16, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Unstable” (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
- Adverse Event Without Identified Device or Use Problem1
- Unstable1
Patient problems
- Joint Laxity1
- Medical device site infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO INFECTION. PRE-EXISTING SMR REVERSE LINER STD 36MM (PN 1360.54.810, LOT 25AT37T, STERILIZATION 2500177) ORIGINALLY IMPLANTED ON (B)(6) 2026 WAS REMOVED AND REPLACED WITH A NEW ONE. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1954. THE EVENT OCCURRED IN THE UNITED STATES.
Patient problems: Medical device site infection
MAUDE report 25519177 ↗InjuryMay 26, 2026Unstable
REVISION SURGERY OCCURRED ON (B)(6) 2026, DUE TO INSTABILITY. ORIGINAL SURGERY OCCURRED ON (B)(6) 2025, AND SHOULDER PROSTHESIS CONSISTING OF DJO ALTIVATE REVERSE COMPONENTS ONLY HAS BEEN IMPLANTED. AFTER FAILURE OF DJO HUMERAL IMPLANT, FIRST REVISION SURGERY FOR THIS PATIENT WAS PERFORMED ON (B)(6) 2026, AND FOLLOWING LIMA REVERSE HUMERAL COMPONENTS WERE IMPLANTED: CEMENTLESS FINNED STEM L.80MM (PN 1304.15.180, LOT. 22523308, STER. (B)(4)) 140° HUMERAL BODY REVERSE (PN 1352.15.011, LOT. 2525679, STER. (B)(4) REVERSE LINER STD DIA. 36 MM (PN 1360.54.810, LOT. 24AT3AQ, STER. (B)(4) SECOND REVISION SURGERY, HEREBY REPORTED, OCCURRED ON (B)(6) 2026 DUE TO INSTABILITY. ABOVE-MENTIONED REVERSE LINER AND HUMERAL BODY WERE REMOVED AND REPLACED WITH NEW HUMERAL BODY (PN 1352.15.011) AND REVERSE LINER STD DIA. 40 MM (PN 1365.54.811). PRE-EXISTING DJO GLENOSPHERE DIA36MM WAS ALSO REPLACED WITH A BIGGER ONE (DIA40MM). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6)1963. THE EVENT OCCURRED IN THE UNITED STATES.
Patient problems: Joint Laxity
MAUDE report 25275494 ↗
Other Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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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