SMR Shoulder 1375.15.515Recalls & reported problems
Limacorporate SPA · SMR Shoulder - TT Augmented 360 Baseplate 15°; S-R; Dia.27 mm · Class 2 · Implant
All models of SMR Shoulder (67)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390267922), received between Apr 24, 2024 and Apr 24, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical 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
- Mechanical Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2024Mechanical Problem; Mechanical Problem
ON (B)(6) 2024 DURING A PRIMARY IMPLANT PROCEDURE, AFTER APPLYING THE METAGLENA AND THE GLENOSPHERE CORRECTLY, THE HUMERUS COULD NOT LUXATED. AFTER SEVERAL ATTEMPTS, IT WAS DECIDED BY THE SURGEON TO REMOVE THE GLENOSPHERE IN ORDER TO DO A HUMERAL RECUT. WITH THE AVAILABLE INSTRUMENTS THE SURGEON WAS ABLE TO DISASSEMBLE THE GLENOSPHERE BUT DURING THE REMOVAL MANEUVER THE TT AUGM.360 BASEPLATE WAS ALSO MOBILIZED. GIVEN THE IMPOSSIBILITY OF REMOVING THE MOBILIZED COMPONENT, SINCE THERE WAS A REASONABLE POSSIBILITY TO CAUSE NEUROVASCULAR AND BONE DAMAGE; AND NOTICING THE ABSENCE OF CONSEQUENCES ON THE STABILITY OF THE IMPLANT (WHICH APPEARED MECHANICALLY GOOD), THE PROCEDURE WAS EFFECTIVELY CONCLUDED. IT WAS REPORTED DELAY DURING THE PROCEDURE DUE TO X-RAY CHECKS DURING AND AT THE END OF THE OPERATION. THIS WAS A PRIMARY PROCEDURE. PATIENT: FEMALE, 76 YEARS OLD, NO RELEVANT PATHOLOGIES. THE FOLLOWING DEVICES WERE IMPLANTED: SMR REVERSE HP GLENOSPH. 40 MM (PRODUCT CODE: 1374.50.400, LOT. 2405596 - STER. (B)(4)) - SOLD IN US. TT AUGM.360 BASEPLATE #S-R 15° (PRODUCT CODE: 1375.15.515, LOT. 2332886 - STER. (B)(4)) - SOLD IN US. SMR CONNECTOR SMALL R (PRODUCT CODE: 1374.15.305, LOT. 2404748
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19170892 ↗
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 13, 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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