SMR Shoulder 1374.15.322Recalls & reported problems
Limacorporate SPA · SMR Shoulder - Connector Lat +2 mm + Screw SMALL / STD · Class 2 · Implant
All models of SMR Shoulder (67)
Data updated Oct 18, 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 08033390268073), received between Jan 7, 2025 and Jan 7, 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 18, 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.
InjuryJan 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESES PERFORMED ON (B)(6) 2024, DUE TO DEEP INFECTION. A WASHOUT WAS PERFORMED ON (B)(6), THEN A FORMAL DAIR WAS DONE ON (B)(6) 2024. DURING THE DAIR PROCEDURE, THE FOLLOWING DEVICES WERE EXPLANTED: SMR REVERSE HP LATERALIZING LINER LONG (PRODUCT CODE: 1362.09.120, LOT#: 2114644 - STER. 2100274) - PRODUCT NOT SOLD IN THE US. SMR SMALL/STD CONNECTOR +2 (PRODUCT CODE: 1374.15.322, LOT#: 2412566 - STER. 2400120). SMR REVERSE HP GLENOSPHERE 44 MM (PRODUCT CODE: 1374.50.440, LOT#: 2410886 - STER. 2400092) PRODUCT NOT SOLD IN THE US. ORGANISM CULTURED P. ACNES. DEVICES OF SAME SIZES WERE IMPLANTED. PREVIOUS SURGERY ON (B)(6) 2024. PATIENT IS A MALE, 74 YEARS OLD, ASA 3. EVENT HAPPENED IN AUSTRALIA.
Patient problems: Medical device site infection
MAUDE report 21091081 ↗
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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