SMR Shoulder 1375.15.507Recalls & reported problems
Limacorporate SPA · SMR Shoulder - TT Augmented 360 Baseplate 7°; S-R; Dia.27 mm · 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 08033390267854), received between Feb 18, 2026 and Feb 18, 2026 — classified as 1 injury.
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
Patient problems
- Implant Pain1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem
REVISION OF SMR REVERSE SHOULDER ARTHROPLASTY PERFORMED ON (B)(6) DUE TO PERSISTENT PAIN. THE SURGEON ATTEMPTED REVISION OF THE BASEPLATE. THE GLENOSPHERE, CONNECTOR, SCREWS, AND BASEPLATE WERE REMOVED. THE CENTRAL PEG REMAINED IN SITU, AS IT WAS WELL FIXED. THE HUMERAL COMPONENT WAS RETAINED IN SITU AND NO INDICATION OF INFECTION WAS OBSERVED. THE PREVIOUS PROCEDURE HAD BEEN PERFORMED ON (B)(6) 2025. THE FOLLOWING DEVICES WERE EXPLANTED: SMR REV. HP LAT. LINER MEDIUM (PRODUCT CODE 1365.09.115, LOT# 2403794, STER. (B)(4), SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT# 2432918, STER. (B)(4), SMR REVERSE HP GLENOSPH. 40 MM (PRODUCT CODE 1374.50.400, LOT# 2500696, STER. (B)(4), TT AUGM.360 BASEPLATE #S-R 7° (PRODUCT CODE 1375.15.507, LOT# 2319067, STER. (B)(4), BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT# 2417486, STER. (B)(4), BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT# 2436172, STER. (B)(4), BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT# 2425715, STER. (B)(4). PATIENT IS FEMALE 62 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.
Patient problems: Implant Pain; Pain
MAUDE report 24377893 ↗
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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