ACTIS 101011050Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 10603295380450), received between Dec 6, 2017 and Sep 18, 2026 — classified as 58 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that actis retaining stem inserter/extractor shaft broke in actis stem while trying to explant it. Removed stem due to infection, all pieces were retrieved no delay in case.Affected side: Right.

  Patient problems: Unspecified Infection

  MAUDE report 50816766 ↗
• InjuryJul 1, 2026Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT FELL WHICH CAUSED PERIPROSTHETIC FRACTURE. THIS LED TO A DISLOCATION. THE STEM ROTATED. IT WAS REMOVED AND A MONOBLOC RECLAIM WAS PLACED. IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO ASEPTIC STEM LOOSENING AT NON-CEMENTED INTERFACE. AFFECTED SIDE: RIGHT.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 25676651 ↗
• InjuryMay 29, 2026Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSE STEM. IT WAS STATED THAT STEM WAS LOOSE LOOSENING INTERFACE WAS MARKED AS THE BONE TO IMPLANT INTERFACE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25330570 ↗
• InjuryApr 9, 2026Osseointegration Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING. DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: (B)(6) 2026. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2026. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: REVISION, COMPONENTS REMOVED (STEM, HEAD). DEPUY SYNTHES PRODUCTS USED. CATALOG NUMBER: 101011050. LOT NUMBER: D25081131. COMPONENT TYPE: STEM. DESCRIPTION: ACTIS COLLARED STANDARD FEMORAL STEM SZ 5. CATALOG NUMBER: 473440050. LOT NUMBER: 10678B. COMPONENT TYPE: HEAD. DESCRIPTION: CERASURF HD 40 +5. CATALOG NUMBER: 472254040. LOT NUMBER: 4916929. COMPONENT TYPE: LINER. DESCRIPTION: EMSYS LNR AOX N 54X40. CATALOG NUMBER: 471054300. LOT NUMBER: 4879500. COMPONENT TYPE: SHELL. DESCRIPTION: EMSYS SHL 3HOLE 54.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24829444 ↗
• MalfunctionApr 7, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE DOCTOR REAMED WITH A SIZE 5 RASP FOR A COLLARED ACTIS STEM, IMPLANT SIZE 5 STD. WHEN POSITIONING THE IMPLANT IN THE FEMORAL CANAL, THEY REALIZED IT WAS COMPLETELY LOOSE. IT CAME OUT BY HAND; THERE WAS NO PRESS-FIT. THEY HAD TO INCREASE THE IMPLANT SIZE BY ONE TO SIZE 6. THERE WAS NO PATIENT HARM. AFFECTED SIDE: RIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802552 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTED HIP IN WHICH MULTIPLE WASHOUTS DID NOT CLEAR THE INFECTION. SURGEON REMOVED IMPLANTS AND PUT IN AN ANTIBIOTIC SPACER. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24768946 ↗
• InjuryMar 6, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED THAT DUE TO STEM LOOSENING. AFFECTED SIDE- LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24530348 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION OCCURRED ON (B)(6) 2025 DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23743751 ↗
• InjuryOct 31, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT FELL AND FRACTURED FEMUR. THERE WAS LOOSENING OF STEM AT NON-CEMENTED INTERFACE. CEMENT MANUFACTURE WAS UNKNOWN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 23434646 ↗
• InjurySep 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE CONE OF A CEMENTLESS HIP PROSTHESIS FRACTURED.

  Patient problems: Insufficient Information

  MAUDE report 23050187 ↗
• MalfunctionSep 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE IMPLANTING A 5 STANDARD ACTIS COLLARED, THE SURGEON NOTICED AFTER PLACING AN ARTICULEZE CERAMIC +1.5 HEAD BALL THAT IT WAS SITTING TOO LOW ON THE TRUNION. THEN TRIALED IT WITH THE +1.5 36 TRIAL AND IT WAS STILL SITTING TOO LOW. USING THE ACTIS REAMERS, FEMORAL STEM WAS TAKEN AND PUT IN A NEW STEM AND SURGEON WAS STILL HAVING THE SAME ISSUES. MORE FILMS WERE TAKEN AND COMPARED THE NUMBERS FOR LEG LENGTH AND OFFSET USING VHN. THE CORRECT NUMBERS FROM THE SECOND STEM WERE RECEIVED COMPARED TO WHAT THEY SHOULD BE FROM THE BROACH AND NECK TRIAL WITHIN 1 MM OF ACCURACY. AFFECTED SIDE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015252 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED HIP DUE TO POOR BONE QUALITY. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22921951 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS A ACTIS REVISION CASE. PERIPROSTHETIC FRACTURE WITH A HIP REPLACEMENT COMPLETED. REPLACED WITH LONG EXETER STEM.

  Patient problems: Fall; Limb Fracture

  MAUDE report 22792128 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECENTLY HAD A TOTAL HIP DONE AND FELL. PATIENT TOLD THE SURGEON WHEN PATIENT FELL. PATIENT HEARD A POP. THE SURGEON WAS CONCERNED BECAUSE OF HER HIGH BMI AND HE GOT AN MRI. ON THE MRI SCAN, SURGEON THOUGHT HE SAW A FRACTURE OF THE ACTIS STEM AT THE NECK. HOWEVER, ON THE REVISION SURGERY AND OPENING UP THE PATIENT, THE ACTIS STEM WAS PERFECTLY FINE. SURGEON TOOK THE NOISE THE PATIENT TOLD HIM AS POSSIBLY THE GREATER TROC BREAKING. SURGEON DID HOWEVER REMOVE THE STEM, HEAD, AND POLY BECAUSE HE HAD SUSPICION OF INFECTION. THERE WERE NO ISSUES WITH ANY OF OUR PRODUCTS. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 22319148 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A PRESUMED INFECTION SO THE SURGEON DECIDED TO WASH OUT AND REMOVE ALL THE IMPLANTS. DOI: UNKNOWN, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22004962 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO THIGH PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 21921882 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21733716 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 21655088 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS UNSTABLE DUE TO DEMENTIA/POST OP PROTOCOL. DOI: UNKNOWN; DOR: (B)(6) 2025; AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 21641941 ↗
• InjuryMar 12, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AT THE BONE TO IMPLANT INTERFACE. PATIENT REPORTS SHE HAD A FALL AT HOME AFTER TAKING MULTIPLE OXY AND DRINKING ETOH. HAD A PERIPROSTHETIC FEMORAL FRACTURE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 21584286 ↗
• InjuryJan 29, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. EXPLANTED ACTIS STEM. IT WAS REPORTED THAT THE LOOSE COMPONENT WAS THE 5 STD ACTIS STEM. LOOSENING INTERFACE WAS REPORTED AS NOT APPLICABLE; THE CEMENT MANUFACTURER WAS UNKNOWN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 21263115 ↗
• InjuryJan 2, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO STEM AND FEMUR LOOSENING. THE REVISION PROCEDURE WAS COMPLETED WITH NO DELAY OR CONSEQUENCES TO THE PATIENT. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21054360 ↗
• MalfunctionDec 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS WASTED ACTIS STEM. THE SURGEON BROACHED THE FEMUR AS NORMAL. LAST BROACH USED WAS A SIZE 5. THE SIZE 5 IMPLANT WAS OPENED AND IT DID NOT SIT DOWN IN THE FEMUR AS FAR AS IT USUALLY DOES. THE SURGEON THEN WENT BACK TO THE SIZE 5 BROACH AND IT SANK IN THE FEMUR A SECOND TIME. AGAIN THE SURGEON THEN PUT THE IMPLANT IN THE FEMUR AND IMPACTED IT WITH THE KINCISE IMPACTOR AS NORMAL. IT WOULD NOT FULLY SEAT SO WE HAD TO EXTRACT THE IMPLANT. ANOTHER SIZE 5 IMPLANT WAS OPENED AND IT SEATED AS NORMAL. IT APPEARED THERE WAS A MISMATCH BETWEEN THE WASTED SIZE 5 IMPLANT AND THE BROACH THAT WAS MORE THAN NORMAL. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20817942 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20633217 ↗
• MalfunctionNov 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT SURGEON BROACHED TO A 5, DISTALLY REAMED TO A 5, REAL STEM SAT ALL THE WAY DOWN, WHICH WAS NOT STABLE IN THE FEMUR. SURGEON HAD TO GO UP IN STEM SIZE. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20585924 ↗