SMR Shoulder Trial StemRecalls & reported problems
Limacorporate SPA · Trial Stem with Quick Connection Dia. 14 mm · Class 2
- 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 08033390122115), received between Jan 2, 2026 and Jan 2, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- 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.
MalfunctionJan 2, 2026Break
DURING REVERSE SHOULDER ARTHROPLASTY SURGERY PERFORMED ON (B)(6) 2025, WHILE BROACHING THE HUMERAL CANAL, THE QUICK CONNECT STEM IMPACTOR TIP (PART NUMBER 9013.02.142, LOT UNKNOWN) BROKE OFF INSIDE THE STEM TRIAL AS THE SURGEON WAS HITTING IT. TRIAL STEM WITH THE TIP OF THE BROACH HANDLE REMAINED STUCK INSIDE THE PATIENT AND COULD NOT BE REMOVED WITH STEM EXTRACTOR (PN 9013.02.301). MEDICAL TEAM USED OTHERS INSTRUMENTS AT THE FACILITY TO RETRIEVE THE BROKEN AND STUCK COMPONENTS. NO FRAGMENTS WERE LEFT IN PATIENT. SURGERY WAS PROLONGED OF ABOUT 20 MINUTES DUE TO REPORTED ISSUE BUT WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. NO IMPACT ON PATIENT HAS BEEN REPORTED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1962. THE EVENT OCCURRED IN THE UNITED STATES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23944366 ↗
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 320-38-00Exactech, 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.