ACTIS 2010-02-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295393849), received between Aug 2, 2018 and Sep 9, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (14 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 15 most recent of 15 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 50689493 ↗
• 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 10606336 ↗
• 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 10606318 ↗
• 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 10606185 ↗
• 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 9220461 ↗
• 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 9220460 ↗
• 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 9220457 ↗
• 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, IP-00576625 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-00576626 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-00576627 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-00576628 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-00576629 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-00576630 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-00576631 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-00576632 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-00576633 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-00576634 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-00576635 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-00576636 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAIL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633950 ↗
• 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 8633849 ↗
• MalfunctionMay 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  NECK SEGMENT IS LOOSE ON BROACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8631855 ↗
• MalfunctionMay 21, 2019Device-Device Incompatibility; Device-Device Incompatibility

  NECK SEGMENT IS LOOSE ON BROACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8629053 ↗
• 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 8591462 ↗
• 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 8591370 ↗
• 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 8591121 ↗
• 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 7742606 ↗