ACTIS 2010-02-450Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295393818), received between Aug 2, 2018 and Sep 9, 2026 — classified as 20 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 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 ordered all new sets of broaches with the new Design in case this happens again, then surgeon will be able to easily extract a broach.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50689571 ↗
• MalfunctionFeb 3, 2025Break; Break

  IT WAS REPORTED THAT THE RING AROUND NECK TRIAL BROKE OFF. NO FRAGMENTS WERE GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21297805 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT METAL RING TO HOLD THE TRIAL HEAD SNAPPED OFF. SURGICAL DELAY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21081632 ↗
• MalfunctionAug 12, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RING CAME OFF THE NECK TRIAL ON THE BACK TABLE. THE RING WAS LOCATED AND DID NOT AFFECT THE PATIENT. THE NECK SEGMENT WAS DISPOSED OFF BY STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19965612 ↗
• MalfunctionJun 20, 2024Break; Break

  IT WAS REPORTED THAT THE LOCKING RING ON THE NECK TRIAL BROKE OFF. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19573774 ↗
• MalfunctionJan 16, 2024Break; Break

  IT WAS REPORTED THAT THE METAL WAS CHIPPED. IT WAS UNKNOWN ABOUT SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 18516646 ↗
• 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 10606269 ↗
• 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 10606131 ↗
• MalfunctionOct 22, 2019Fitting Problem; Device-Device Incompatibility; Fitting Problem; 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 9220627 ↗
• MalfunctionOct 22, 2019Fitting Problem; Device-Device Incompatibility; Fitting Problem; 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 9220624 ↗
• MalfunctionOct 22, 2019Fitting Problem; Device-Device Incompatibility; Fitting Problem; 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 9220609 ↗
• MalfunctionJul 9, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON WAS REDUCING THE HIP DURING TRIAL REDUCTION AND THE NECK SEGMENT DISASSOCIATED FROM THE TRIAL BROACH. THIS CAUSED A DELAY IN SURGERY AS SURGEON HAD TO DISLOCATE THE HIP, RE-ATTACH THE SEGMENT, AND THEN REDUCE THE HIP AGAIN. THIS ALSO PREVENTS THE SURGEON FROM BEING ABLE TO ACCURATELY ASSESS PATIENTS LEG LENGTHS DURING TRIAL REDUCTION.

  Patient problems: Not Applicable

  MAUDE report 8773027 ↗
• 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 8633962 ↗
• 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 8633861 ↗
• MalfunctionMay 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  NECK SEGMENT IS LOOSE ON BROACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8631835 ↗
• MalfunctionMay 21, 2019Device-Device Incompatibility; Device-Device Incompatibility

  NECK SEGMENT IS LOOSE ON BROACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8629013 ↗
• 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 8591468 ↗
• 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 8591344 ↗
• 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 8591076 ↗
• 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 7742727 ↗