ACTIS 2010-02-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295393801), received between Jul 19, 2018 and Sep 9, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (15 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.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Break; Device-Device Incompatibility

  It was reported that the Broaches were broke during a case. Surgeon needed to order all new sets of broaches with the new design in case this happens again.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50689410 ↗
• MalfunctionMay 14, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY PROCEDURE IT WAS OBSERVED THAT THE HEAD BALL WOULD NOT SIT ON NECK TRIALS. IT WAS REPORTED THAT THE DEVICE KEPT COMING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175996 ↗
• MalfunctionJul 7, 2025Break; Break

  IT WAS REPORTED THAT STAFF NOTICED METAL RING AROUND NECK WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22418364 ↗
• MalfunctionApr 29, 2024Break; Break

  IT WAS REPORTED THAT THERE WAS A SNAPPED RING. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201299 ↗
• MalfunctionAug 9, 2022Break; Break

  IT WAS REPORTED THAT THE RING BROKE OFF THE NECK TRIAL. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15193263 ↗
• MalfunctionSep 30, 2020Loose or Intermittent Connection; Device-Device Incompatibility; Material Twisted/Bent; Loose or Intermittent Connection; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE ACTIS TRIAL NECK SEGMENTS LOOSE TOLERANCE AND SLIGHTLY DISENGAGING WHEN TRIALING HIP. NO PROBLEMS WERE CAUSED DUE TO WORN INSTRUMENT. NEW NECK SEGMENTS WERE SWAPPED TO ADDRESS THIS ISSUES. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10606251 ↗
• MalfunctionSep 30, 2020Loose or Intermittent Connection; Device-Device Incompatibility; Material Twisted/Bent; Loose or Intermittent Connection; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE ACTIS TRIAL NECK SEGMENTS LOOSE TOLERANCE AND SLIGHTLY DISENGAGING WHEN TRAILING HIP. NO PROBLEMS WERE CAUSED DUE TO WORN INSTRUMENT. NEW NECK SEGMENTS WERE SWAPPED TO ADDRESS THIS ISSUES. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10606122 ↗
• MalfunctionOct 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ACTIS TRIAL NECKS KEEP SLIDING OFF BROACHES . THEY CALLED R.O IN HIP MARKETING AND TOLD THEY HAVE FIXED THIS ISSUE IN THE NEWER SETS. NEEDING TO GET THREE SETS OF TRIAL NECKS FOR ACTIS STANDARD AND HIGH OFFSET . R.O TOLD HIM TO FILL OUT MDR FORM AND I CLD GET OLDER STYLE ACTIS NECKS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9220446 ↗
• MalfunctionOct 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ACTIS TRIAL NECKS KEEP SLIDING OFF BROACHES. THEY CALLED R.O IN HIP MARKETING AND TOLD THEY HAVE FIXED THIS ISSUE IN THE NEWER SETS. NEEDING TO GET THREE SETS OF TRIAL NECKS FOR ACTIS STANDARD AND HIGH OFFSET . R.O TOLD HIM TO FILL OUT MDR FORM AND I CLD GET OLDER STYLE ACTIS NECKS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9220436 ↗
• MalfunctionOct 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ACTIS TRIAL NECKS KEEP SLIDING OFF BROACHES . THEY CALLED R.O IN HIP MARKETING AND TOLD THEY HAVE FIXED THIS ISSUE IN THE NEWER SETS. NEEDING TO GET THREE SETS OF TRIAL NECKS FOR ACTIS STANDARD AND HIGH OFFSET . R.O TOLD HIM TO FILL OUT MDR FORM AND I CLD GET OLDER STYLE ACTIS NECKS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9217819 ↗
• MalfunctionMay 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  NECK SEGMENT IS LOOSE ON BROACH 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, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (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 Consequences Or Impact To Patient

  MAUDE report 8633949 ↗
• MalfunctionMay 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  NECK SEGMENT IS LOOSE ON BROACH. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633847 ↗
• MalfunctionMay 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  NECK SEGMENT IS LOOSE ON BROACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8631870 ↗
• MalfunctionMay 21, 2019Device-Device Incompatibility; Device-Device Incompatibility

  NECK SEGMENT IS LOOSE ON BROACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8629115 ↗
• MalfunctionMay 8, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ACTIS NECK TRIALS HAVE BEEN COMING APART DURING TRIAL REDUCTIONS. FORCING THE SURGEON TO DISLOCATE HIP, DROP THE LEG, RECONNECT THE NECK TRIAL, AND REDUCE THE HIP AGAIN. THIS HAS BEEN AN ONGOING ISSUE WITH OUR SETS, AND HAS ADDED TIME TO PROCEDURES. WE HAVE 3 SETS IN OUR HOSPITAL THAT NEED TO BE CHANGED OUT.

  Patient problems: Not Applicable

  MAUDE report 8591463 ↗
• MalfunctionMay 8, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ACTIS NECK TRIALS HAVE BEEN COMING APART DURING TRIAL REDUCTIONS. FORCING THE SURGEON TO DISLOCATE HIP, DROP THE LEG, RECONNECT THE NECK TRIAL, AND REDUCE THE HIP AGAIN. THIS HAS BEEN AN ONGOING ISSUE WITH OUR SETS, AND HAS ADDED TIME TO PROCEDURES. WE HAVE 3 SETS IN OUR HOSPITAL THAT NEED TO BE CHANGED OUT.

  Patient problems: Not Applicable

  MAUDE report 8591369 ↗
• MalfunctionMay 8, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ACTIS NECK TRIALS HAVE BEEN COMING APART DURING TRIAL REDUCTIONS. FORCING THE SURGEON TO DISLOCATE HIP, DROP THE LEG, RECONNECT THE NECK TRIAL, AND REDUCE THE HIP AGAIN. THIS HAS BEEN AN ONGOING ISSUE WITH OUR SETS, AND HAS ADDED TIME TO PROCEDURES. WE HAVE 3 SETS IN OUR HOSPITAL THAT NEED TO BE CHANGED OUT.

  Patient problems: Not Applicable

  MAUDE report 8591142 ↗
• MalfunctionDec 3, 2018Stretched; Device-Device Incompatibility; Material Twisted/Bent; Stretched; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE BOTH NECK SEGMENTS HAVE STRETCHED OUT LOCKING RINGS NOT ALLOWING A HEAD TRIAL TO CONNECT PROPERLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8125233 ↗
• MalfunctionAug 2, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  USER REPORTED THAT FOR THE ACTIS TRIAL NECKS "IT WOULD BE AN IMPROVEMENT IF THE ¿FEMALE" TRIAL NECK HAD AN O RING IN THE HOLE SO THAT THE NECK WOULD NOT COME OFF DURING TRIAL REDUCTION AND DISLOCATION." COMPLAINT BEING RAISED AS USE INDICATED THAT THE NECK WOULD COME OFF DURING TRIALING AND DISLOCATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7742564 ↗
• MalfunctionJul 19, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE ACTIS 6/7 STD NECK TRIAL RING IS BROKEN. THE PIECE HAS EXPANDED AND WILL NO LONGER ALLOW THE HEAD TRIAL TO SNAP IN. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7702413 ↗