ACTIS 2010-02-350Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295393795), received between Aug 2, 2018 and Sep 9, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (16 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 19 most recent of 19 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 50689662 ↗
• MalfunctionSep 2, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50554763 ↗
• MalfunctionMar 11, 2025Break; Break

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE THE 4/5 HIGH NECK SEGMENT RING CAME OFF THE NECK TRIAL AND NEEDED REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 21575303 ↗
• MalfunctionSep 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NECK TRIALS WEREN'T HOLDING THE HEADS.

  Patient problems: Insufficient Information

  MAUDE report 20245513 ↗
• MalfunctionJun 6, 2023Break; Break

  IT WAS REPORTED THAT THE NECK OF THE RING BROKE ON THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071925 ↗
• MalfunctionJun 17, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THE TRIAL NECK WOULD NOT CAPTURE HEAD TRIAL WHILE TRIALING. IT WOULD FALL OFF WHEN ANY FORCE WAS APPLIED TO IT. ALTERNATE BROACH TRAY WAS USED TO FINISH THE CASE. A LONGER HEAD WAS USED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14734779 ↗
• 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 10606244 ↗
• 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 10606116 ↗
• 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 9220612 ↗
• 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 9220595 ↗
• 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 9220594 ↗
• 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 8633964 ↗
• 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 8633853 ↗
• MalfunctionMay 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  NECK SEGMENT IS LOOSE ON BROACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8631840 ↗
• MalfunctionMay 21, 2019Device-Device Incompatibility; Device-Device Incompatibility

  NECK SEGMENT IS LOOSE ON BROACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8629077 ↗
• 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 8591469 ↗
• 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 8591347 ↗
• 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 8591081 ↗
• 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 7742703 ↗