SMR Shoulder system 9013.02.301Recalls & reported problems
Limacorporate SPA · Stem Extractor · Class 1
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 08033390097987), received between Sep 19, 2025 and Sep 11, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
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.
MalfunctionSep 11, 2026Break
During an SMR revision performed on (b)(6) 2026, an intraoperative issue occurred. While the humeral components were being removed using the stem extractor, the extractor was struck with a mallet to remove the stem. During this maneuver, the threaded portion of the extractor broke and remained lodged inside the stem. The event resulted in an approximately 20-minute delay to the surgical procedure.The surgeon followed the standard surgical workflow for shoulder revision. The involved instrument was:SMR - STEM EXTRACTOR (Product code 9013.02.301, lot 14AA150A).Event happened in Australia.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50729553 ↗MalfunctionSep 19, 2025Break; Break
DURING A REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO LOW GRAD INFECTION, AN INTRAOPERATIVE ISSUE OCCURRED. WHEN EXPLANTING THE STEM, THE THREAD OF SMR - STEM EXTRACTOR (PRODUCT CODE: 9013.02.301 - LOT: 15AA269A) BROKE. THE STEM REMAINED IN THE HUMERAL BONE. THE OPERATOR HAD TO SAW THE BONE TO EXPLANT THE HUMERAL STEM (PRODUCT CODE: 1304.15.190 - LOT: 2400630). THEN THE BONE WAS FIXED WITH CERCLAGES. THE SURGERY WAS PROLONGED ABOUT 25 MINUTES. FOR THE REVISION SURGERY PROCEDURE COMPLAITN NUMBER (B)(4) (MDR REPORT NUMBER 3008021110-2025-00128) WAS CREATED AND WILL BE SUBMITTED SEPARATELY. EVENT OCCURRED IN GERMANY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23096027 ↗
Other Extractor devices
- ATTUNE 2545-00-138Depuy (Ireland) · EXTRACTOR392 reports
- PINNACLE 2217-50-001Depuy (Ireland) · EXTRACTOR243 reports
- RECLAIM 2975-00-635Depuy (Ireland) · EXTRACTOR157 reports
- ATTUNE 2545-00-060Depuy (Ireland) · EXTRACTOR153 reports
- ESC PINNACLE 2218-00-010Depuy (Ireland) · EXTRACTOR151 reports
- NA 2125-00-600Depuy Orthopaedics, Inc. · EXTRACTOR130 reports
- P.F.C. 86-5226Depuy (Ireland) · EXTRACTOR80 reports
- NA 03.010.000Synthes GmbH · EXTRACTOR74 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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