SMR Shoulder Humeral Body (REF 1350.15.010)Recalls & reported problems
Limacorporate SPA · Trauma humeral bodies with locking screw Medium · 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 08033390002004), received between Jul 9, 2025 and Jul 9, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K100858); they may or may not involve this specific model.
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
- Osteolysis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO LOOSENING. PATIENT HAD A LIMA ANATOMIC REPLACEMENT AT UNKNOWN PRIOR DATE. DUE TO LOOSENING OF CEMENTED 3-PEGGED GLENOID COMPONENT, SIGNIFICANT OSTEOLYSIS OCCURRED. AFTER REMOVING THE GLENOID COMPONENT, A MIXTURE OF BONE GRAFT AND DEMINERALIZED BONE MATRIX WAS USED TO PACK THE DEFECT. THIS WAS THE SECOND STAGE IN THE TWO-STAGE REVISION PROCESS. THE FOLLOWING ANATOMIC BODY, HEAD AND ADAPTOR WERE REMOVED: - SMR HUMERAL HEAD Ø44 MM (PART CODE 1322.09.440, LOT NUMBER 1919684, STERILIZATION (B)(4)) - SMR ECC.ADAPTOR TAPER STANDARD (PART CODE 1330.15.272, LOT UMBER 2023555, STERILIZATION (B)(4)). - SMR TRAUMA HUM. BODY # MEDIUM (PART CODE 1350.15.010, LOT NUMBER 2023593, STERILIZATION (B)(4)). A REVERSE BODY AND PRIMA TT BASEPLATE WERE IMPLANTED INTO THE PREVIOUSLY GRAFTER GLENOID. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6)1953. THE EVENT HAPPENED IN THE UNITED STATES.
Patient problems: Osteolysis
MAUDE report 22458124 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K100858. One submission often covers many models, so check the product and lot details in each record.
- Z-2539-2015 · Aug 14, 2015 · TerminatedSMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral
- Z-2540-2015 · Aug 14, 2015 · TerminatedSMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
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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