SMR System 1375.15.620Recalls & reported problems
Limacorporate SPA · SMR System - TT Baseplate Small · 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 08033390272810), received between Jun 24, 2026 and Jun 24, 2026 — 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 16, 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.
InjuryJun 24, 2026Patient Device Interaction Problem
A SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO INFECTION. THE SURGEON GAINED ACCESS TO THE SHOULDER AND COLLECTED MULTIPLE SPECIMENS FROM DIFFERENT ANATOMIES AND TISSUES FOR TESTING. ALL IMPLANTS WERE THEN REMOVED, TISSUE DEBRIDEMENT WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED WITH IMPLANTATION OF A ZIMMER CEMENT SPACER WHILE TREATING THE INFECTION. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2026. THE SURGEON FOLLOWED THE STANDARD SURGICAL WORKFLOW FOR SHOULDER REVISION. THE EXPLANTED COMPONENTS INCLUDED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.180, LOT 2430739, STER. N. 2400261); SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT 2511800, STER. N. 2500108); SMR REV. HP LAT. LINER MEDIUM (PRODUCT CODE 1362.09.115, LOT 2505487, STER. N. 2500076); SMR SMALL/STD CONNECTOR +2 (PRODUCT CODE 1374.15.322, LOT 2518095, STER. N. 2500155); SMR REVERSE HP GLENOSPH. 44 MM (PRODUCT CODE 1374.50.440, LOT 2512623, STER. N. 2500093); SMR GLENOID PEG TT S/STD #M (PRODUCT CODE 1375.14.662, LOT 2223558, STER. N. 2300112); SMR GLENOID BASEPLATE SMALL (PRODUCT CODE 1375.15.620, LOT 1701022, STER. N. 2300215); BONE SCREW Ø6,5 H.20 MM (PRODUCT CODE 8420.15.010, LOT 2
Patient problems: Medical device site infection
MAUDE report 25606224 ↗
Other Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented devices
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-00Exactech, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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