SMR Shoulder 9013.75.355Recalls & reported problems
Limacorporate SPA · Shaft for Angled Glenoid Reamer · Class 2
All models of SMR Shoulder (67)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390167277), received between Oct 3, 2024 and Feb 18, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Twisted/Bent1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2026Break
DURING A SHOULDER SURGERY PERFORMED ON (B)(6) 2026, WHILE REAMING FOR A 19-DEGREE AUGMENT, THE SMR SHAFT ANGLED GLEN REAMER (PRODUCT CODE 9013.75.355, LOT NO. 21BH06Q) ENGAGED WITH A RETRACTOR, RESULTING IN FRACTURE OF THE DISTAL TIP OF THE REAMER SHAFT. THE DETACHED PART FELL INTO PATIENT AND THEN REMOVED. AS THIS WAS A REGIONAL CASE, A DROP SET WAS AVAILABLE ON SITE. THE INSTRUMENT WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE SURGERY WAS DELAYED BY LESS THAN 15 MINUTES. THE PATIENT IS A 63-YEAR-OLD MALE. EVENT HAPPENED IN AUSTRALIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377891 ↗MalfunctionOct 3, 2024Mechanical Problem; Material Twisted/Bent; Mechanical Problem; Material Twisted/Bent
BEFORE A SURGERY WITH THE AUGMENTED BASEPLATE STARTED ON (B)(6) 2024, IT WAS NOTICED THAT THE SMR SHAFT ANGLED GLENOID REAMER (PRODUCT CODE 9013.75.355, LOT #22BH0EN) WAS BENT. AS A CONSEQUENCE, AUGMENTED REAMERS COULDN'T BE USED, AND A STANDARD REAMER FOR A STANDARD BASEPLATE WAS USED INSTEAD. THE BEND WAS NOTICED BEFORE SURGERY STARTED, NO SIGNIFICANT EXTENSION OF THE SURGICAL TIME. IT WAS REPORTED THAT THE SURGEON WAS SATISFIED WITH THE STABILITY OF THE FINAL IMPLANTATION. NUMBER OF USES OF THE INSTRUMENT IS UNKNOWN. EVENT HAPPENED IN AUSTRALIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20358700 ↗
Other Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented devices
- COMPREHENSIVE SHOULDER SYSTEM 113629Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall2 reports
- COMPREHENSIVE SHOULDER SYSTEM 113617Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall1 report
- Comprehensive® Shoulder System 113607Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall1 report
- COPELAND SHOULDER SYSTEM 11-114647Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COMPRESS DEVICE 178787Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COPELAND SHOULDER SYSTEM 11-114641Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COPELAND SHOULDER SYSTEM 11-114644Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- BIO-MODULAR SHOULDER SYSTEM 113865Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 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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