ACTIS 2010-07-120Recalls & reported problems
Depuy (Ireland) · ACTIS CURVED INSERTER SHAFT · Class 1
All models of ACTIS (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Actis curved inserter shaft is a surgical instrument used during hip replacement surgery. The 49 reports mostly describe the instrument not working with other parts of the DePuy system, sticking or jamming so pieces would not come apart after cleaning, and bending, chipping or breaking during surgery, sometimes causing a delay of a few minutes. No deaths or injuries are described. There are no recalls naming this device, and reports have fallen from 9 to 4 in the last 12 months.
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
- 50
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10603295394006), received between Sep 25, 2018 and Sep 30, 2026 — classified as 50 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (41 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
- Device-Device Incompatibility41
- Break5
- Material Twisted/Bent3
- Material Deformation2
- Mechanical Jam2
- Physical Resistance/Sticking2
- Appropriate Device Problem Term/Code Not Available1
- Corroded1
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- No Consequences Or Impact To Patient7
- Insufficient Information4
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device-Device Incompatibility
It was reported that the emphasys impactor threaded part no longer threads.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946330 ↗MalfunctionSep 15, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781191 ↗MalfunctionAug 18, 2026Device-Device Incompatibility
It was reported that after the instruments went through decontamination process the 2 piece Actis stem inserter and handle would not come apart.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50299073 ↗MalfunctionMay 8, 2026Device-Device Incompatibility
IT WAS REPORTED THAT UNIVERSAL HANDLE AND CURVED STEM INSERTER WERE STUCK TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25123289 ↗MalfunctionMar 31, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DOES NOT FIT IN THE UNIVERSAL INSERTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742066 ↗MalfunctionOct 20, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT. THE TIP CHIPPED OFF OF THE INSERTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23340519 ↗MalfunctionSep 10, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT HAS A LEFT TOTAL HIP. THE 2 PIECE ACTIS STEM INSERTER WAS STUCK TOGETHER AND IT WOULD NOT SEPARATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23014896 ↗MalfunctionAug 12, 2025Break; Break
IT WAS REPORTED THAT THE IMPACTOR FITTING BROKEN DURING SURGERY. BROKE WHEN ONE PIECE FIT INTO ANOTHER. BOTH PIECES BROKEN INTO 2 PIECES. NO FRAGMENTS WERE GENERATED. A NEW INSTRUMENT WAS OPENED TO USE. THERE WAS A 5 MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22786542 ↗MalfunctionAug 11, 2025Corroded; Material Deformation; Corroded; Material Deformation
IT WAS REPORTED THAT RETRACTORS BENTS. THERE WAS METAL PITTING ON INSERTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22769992 ↗MalfunctionJul 30, 2025Break; Device-Device Incompatibility; Material Deformation; Break; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE C-CLAMP ON THE NECK BROKE OFF, THE TIP OF THE STEM INSERTER HAS BEEN DISTORTED AND WILL NOT ENGAGE IN STEM. THIS EVENT DID NOT HAPPEN IN SURGERY. ALL AVAILABLE INFORMATION HAS BEEN FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664129 ↗MalfunctionJun 26, 2025Break; Break
IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22338510 ↗MalfunctionMar 17, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE CURVED INSERTER SEIZED WITH INSERTER HANDLE, WILL NOT DISCONNECT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21621123 ↗MalfunctionFeb 11, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ACTIS IMPACTOR AND UNIVERSAL HANDLE WAS FROZEN TOGETHER AND THEY WERE UNABLE TO SEPARATE IN POST-OP TO WASH AND SANITIZE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21356244 ↗MalfunctionNov 14, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSERTER AND INSERTER HANDLE ARE COLD WELDED TOGETHER, AND COULD NOT COME APART.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20688185 ↗MalfunctionSep 5, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE.
Patient problems: Insufficient Information
MAUDE report 20143981 ↗MalfunctionJun 4, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE UNIVERSAL HANDLE AND CURVED INSERTER BECAME COLD WELDED AND COULD NOT BE REMOVED FROM EACH OTHER. THIS DID NOT DELAY IN THE SURGERY. NO OTHER INFORMATION WAS AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 19458708 ↗MalfunctionJan 29, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ACTIS STEM INSERTER IS STUCK IN THE UNIVERSAL STEM INSERT HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18601154 ↗MalfunctionJan 29, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT STEM INSERTER SHAFT AND HANDLE BECAME FUSED AFTER IMPACTION. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18600239 ↗MalfunctionJan 4, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ACTIS STEM INSERTER AND HANDLE GOT STUCK AND COULD NOT BE PULLED APART AFTER THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18444061 ↗MalfunctionDec 19, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT IMPACTOR HANDLE WAS BROKEN FROM BACK AT STRIKE PLATE. ACTIS CURVED INSERTER SHAFT & UNIVERSAL STEM INSERT HANDLE STUCK TOGETHER, COULD NOT SEPARATE. AND WHITE HANDLE WAS CRACKED.
Patient problems: Insufficient Information
MAUDE report 18354647 ↗MalfunctionDec 4, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE TIPS ON THESE INSERTERS ARE WORN BEYOND USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18261080 ↗MalfunctionAug 25, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ACTIS OFFSET INSERTER IS HOLDING ON TO PROSTHESIS AND NOT RELEASING. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17626123 ↗MalfunctionApr 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE CALCAR PLANAR DISC WOULD NOT THREAD ONTO THE CALCAR PLANAR BASE. IT LOOKED LIKE THE THREADS ON THE BASE WERE WORN OR MIGHT HAVE BEEN CROSS THREADED. THE STEM INSERTER AND HANDLE WERE ALSO STUCK AFTER THE CASE AND COULD NOT BE SEPARATED BY TECH OR REP. IT WAS UNKNOWN ABOUT THE SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16795303 ↗MalfunctionApr 11, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THE STEM INSERTER HAND AND ANTERIOR TIP WERE STUCK TOGETHER. DISCOVERY WAS MADE AFTER SURGERY DURING DECONTAMINATION. NO ADVERSE AFFECTS ON THAT PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16715702 ↗MalfunctionDec 13, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TWO PIECE INSERTER WILL NOT SEPARATE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15968684 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- 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 13, 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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