ACTIS 2010-07-100Recalls & reported problems
Depuy (Ireland) · ACTIS RETAINING STEM INSERTER · Class 1
All models of ACTIS (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ACTIS stem inserter has 200 adverse event reports, with no deaths and no injuries. Many reports describe the tool's threads breaking or wearing out, tips breaking off, or cross-threading, which can make it hard to attach to or remove the stem. Reports dropped to 24 in the last 12 months from 41 in the 12 months before. There are no recalls that name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 209
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 209 adverse event reports that list this exact device (DI 10603295393986), received between Jun 28, 2019 and Sep 29, 2026 — classified as 209 malfunctions.
The most frequently reported specific device problem is “Break” (79 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
- Break79
- Naturally Worn73
- Device-Device Incompatibility45
- Material Deformation42
- Material Twisted/Bent12
- Entrapment of Device10
- Material Integrity Problem3
- No Apparent Adverse Event3
Patient problems
- No Clinical Signs, Symptoms or Conditions174
- Insufficient Information21
- No Consequences Or Impact To Patient15
- Foreign Body In Patient3
- No Code Available2
Recent adverse event reports
The 25 most recent of 209 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937741 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932500 ↗MalfunctionSep 29, 2026Break; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931313 ↗MalfunctionSep 29, 2026Break; Material Deformation
It was reported that threaded Actis distractor needs replaced asap. Threads were cross threaded and tip of other piece was broken. Osteotome handle also needs replaced. The locking mechanism was broken and no longer holds flex osteotomes.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931311 ↗MalfunctionSep 17, 2026Break
It was reported that the actis retaining stem inserter/extractor shaft broke in the actis stem while trying to explant it. The stem was removed due to infection. All pieces were retrieved. There was no delay in case.What was the affected side? Right.DOI: (b)(6) 2021,DOR: (b)(6) 2026,Affected side: Unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803280 ↗MalfunctionSep 16, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791078 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722947 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722944 ↗MalfunctionSep 10, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720197 ↗MalfunctionSep 2, 2026Material Deformation
It was reported that during a Total Hip Replacement surgical procedure it was observed that the threaded inserter was stripped/cross threaded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50555068 ↗MalfunctionAug 13, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50240846 ↗MalfunctionMay 19, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE INSERTER WILL NOT THREAD PROPERLY. ACTIS RETAINING STEM INSERTER (201007100) : SIDE AFFECTED: NOT APPLICABLE ## REASON PRODUCT IS NOT AVAILABLE: AVAILABLE WAS THERE ANY REPORTED PATIENT OR USER HARM? NO. WAS THERE A SIGNIFICANT DELAY? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25221560 ↗MalfunctionMay 13, 2026Break
IT WAS REPORTED THAT THREADED PORTION OF ACTIS THREADED STEM INSERTER BROKE OFF DURING INSERTION INTO TWO PIECES. THEY WERE BOTH RECOVERED. THERE WAS NO DELAY OR NEGATIVE PATIENT OUTCOMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25163322 ↗MalfunctionMay 11, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT PATIENT UNDERWENT HIP SURGERY. THE INSERTER HAD DAMAGED DISTAL THREADS AND COULDN'T CONNECT TO THE IMPLANT PROPERLY TO EXTRACT THE STEM. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25142699 ↗MalfunctionMay 11, 2026Material Deformation
IT WAS REPORTED THAT THE ACTIS THREADED INSERTION HANDLE WAS CROSS THREADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25135196 ↗MalfunctionMay 1, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THREADS WERE DAMAGED, MAKING IT IMPOSSIBLE TO SCREW ON THE IMPLANT OR EXTRACT IT. THE SURGERY WAS DELAYED BY 5 MINUTES. ANOTHER SET WITH THE SAME INSTRUMENT WAS OBTAINED AND USED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25058710 ↗MalfunctionApr 23, 2026Break
IT WAS REPORTED THAT THE ACTIS REAMER EXTRACTOR HAD BROKEN THREADS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966606 ↗MalfunctionApr 16, 2026Break; Material Deformation
IT WAS REPORTED THAT ACTIS EXTRACTION THREADED TIP IS BROKEN AND STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24895791 ↗MalfunctionMar 11, 2026Break
IT WAS REPORTED THAT THE THREADED EXTRACTOR BROKE IN AN ATTEMPT TO EXTRACT A STEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24570902 ↗MalfunctionMar 10, 2026Device-Device Incompatibility
IT WAS REPORTED THAT MULTIPLE ACTIS STEM EXTRACTOR THREADS ARE DULL, IT WOULD NOT THREAD IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557642 ↗MalfunctionMar 10, 2026Device-Device Incompatibility
IT WAS REPORTED THAT MULTIPLE ACTIS STEM EXTRACTOR THREADS ARE DULL, IT WOULD NOT THREAD IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557574 ↗MalfunctionMar 9, 2026Device-Device Incompatibility
VETERINARY COMPLAINT: IT WAS REPORTED THAT MULTIPLE ACTIS STEM EXTRACTORS HAD DULL THREADS. WOULD NOT THREAD IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24545918 ↗MalfunctionMar 9, 2026Device-Device Incompatibility
VETERINARY COMPLAINT: IT WAS REPORTED THAT MULTIPLE ACTIS STEM EXTRACTORS HAD DULL THREADS. WOULD NOT THREAD IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24545917 ↗MalfunctionMar 6, 2026Break
IT WAS REPORTED THAT IT DROPPED DURING WASHING, AND THE BOTTOM SNAPPED OFF. THE THREADS BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24533931 ↗MalfunctionMar 3, 2026Material Deformation
IT WAS REPORTED THAT THE ACTIS STEM REMOVER THREADS WERE STRIPPED. IT WAS NOTICED PRIOR TO USING IT, SO THE DEVICE WAS REPLACED BEFORE IT WAS NEEDED, ALLOWING THE PROCEDURE TO PROCEED WITHOUT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500129 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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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