ACTIS 101012030Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295380559), received between May 23, 2018 and Jun 16, 2026 — classified as 22 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2026Osseointegration Problem; Migration

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO FEMORAL STEM LOOSENING AT BONE TO IMPLANT (NON-CEMENTED) INTERFACE. THIS PATIENT HAS A RIGHT TOTAL HIP WHERE THE FEMORAL STEM HAS SUBSIDED OVER A CENTIMETER AND A HALF. IT IS UNKNOWN WHY THE STEM SUBSIDED INTO AND BELOW THE TOP OF THE LESSER TROCHANTER. DOI: ON (B)(6) 2026, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25519494 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PPFX. PATIENT FELL WHILE MOPPING USING A WALKER. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT.

  Patient problems: Fall; Limb Fracture

  MAUDE report 25148745 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD SINGLE STAGE REVISION. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24790863 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  VOLUNTARY REPORT RECEIVED (MW5178318). I AM REPORTING SERIOUS HARM AND PRODUCT TRACEABILITY ISSUES INVOLVING HIP IMPLANTS USED IN TWO SEPARATE SURGERIES THAT APPEAR TO INVOLVE JOHNSON & JOHNSON/DEPUY SYNTHES DEVICES. BOTH SURGERIES RESULTED IN COMPLICATIONS, PAIN, AND DISABILITY, AND IN BOTH CASES THE IMPLANTS LACKED PROPER IDENTIFICATION OR TRACEABLE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION. FIRST SURGERY (B)(6) 2024 ((B)(6) HOSPITAL, MD): A JOHNSON & JOHNSON/DEPUY REPRESENTATIVE NAMED (B)(6) WAS PRESENT IN THE OPERATING ROOM. THE SURGEON SIGNED OFF ON THE IMPLANT EVEN THOUGH THE IMPLANT SHEET DID NOT CONTAIN SPECIFIC SERIAL OR UNIQUE DEVICE IDENTIFIER (UDI) NUMBERS. THE IMPLANT HAD NO IDENTIFIABLE MARKINGS, MAKING IT COMPLETELY UNTRACEABLE. THIS VIOLATES STANDARD FOOD AND DRUG ADMINISTRATION (FDA) AND HOSPITAL TRACEABILITY RULES. POST-OPERATIVELY, I EXPERIENCED PAIN, INSTABILITY, AND NUMBNESS IN MY LEG. WHEN LATER REVISION SURGERY WAS PERFORMED, THE IMPLANT WAS FOUND TO BE AT A 36-DEGREE ANGLE, IMPROPERLY FITTED,AND FRACTURED, CONFIRMING MECHANICAL AND QUALITY FAILURE. SECOND (REVISION) SURGERY (B)(6) 2025 ((B)(6) HOSPITAL, (B)(6)): THE REVISION SURGEON, DR. (B)(6), DOCUMENTED

  Patient problems: Joint Laxity; Loss of Range of Motion; Numbness; Pain

  MAUDE report 24122205 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION WAS PERFORMED DUE TO PATIENT'S LEG LENGTH DISCREPANCY. SURGEON REVISED AND PUT IN A SHORTER CONSTRUCT. NO LOTS ABLE TO BE RETRIEVED FROM EACH IMPLANT. AFFECTED SIDE: LEFT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 22535020 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DRAINING FROM ORIGINAL IMPLANTATION THE WEEK BEFORE. SURGEON BELIEVES THERE IS SOMETHING GOING ON WITH THE PATIENT¿S HEALTH, NOT IMPLANT OR SURGICAL PROCEDURE ISSUE. ALL IMPLANTS WERE REMOVED AND WASHOUT WAS PERFORMED WITH NOW IMPLANTATION OF ALL IMPLANTS. DOI: (B)(6) 2025 DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 22419214 ↗
• InjuryJul 2, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT STEM AND HEAD WERE REVISED DUE TO STEM SUBSIDING AND LOOSENING. STEM WAS LOOSE AT NON-CEMENTED INTERFACE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22384880 ↗
• InjuryMar 26, 2025Adverse 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 FAILED OF TOTAL HIP. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 21700103 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A HIP REVISION FIVE YEARS POST-IMPLANT. THE PATIENT REPORTED HAVING INCREASING RIGHT HIP PAIN ALONG WITH SUBLUXATION ¿ALMOST DISLOCATING¿. THE PATIENT IS ALSO EXPERIENCING LEFT KNEE SWELLING, WHICH THEY ARE ATTRIBUTING TO THEIR ¿DUCK WALKING¿ DUE TO PAIN IN THE RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 21161076 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND FRACTURED HIP. NEEDED REVISION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE : UNKNOWN.

  Patient problems: Fall; Limb Fracture

  MAUDE report 20521069 ↗
• InjuryOct 1, 2024Migration; Migration

  ADDITIONAL INFORMATION WAS RECEIVED: THERE WAS NO ALLEGATIONS AGAINST THE BIMENTUM IMPLANTS, THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20347352 ↗
• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION TOTAL HIP FOR AN INFECTION. THE SURGEON REMOVED ALL THE IMPLANTS AND INSERTED A HIP ANTIBIOTIC SPACER. NO SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 20002526 ↗
• MalfunctionAug 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHEN THE SURGEON TRIED IMPACTING THE FINAL STEM IMPLANT INTO THE FEMUR, HE WAS UNABLE TO GET THE STEM DOWN ALL THE WAY TO THE CALCAR AND DID NOT WANT THE STEM TO SIT UP AT ALL SO HE DECIDED TO EXTRACT THE STEM. THE THREADED ACTIS STEM EXTRACTOR WOULD NOT THREAD INTO THE STEM SO A ZIMMER EXTRACTION LASSO WAS USED AND IN THE PROCESS OF REMOVING THE STEM, IT WAS DAMAGED. DOI: (B)(6) 2024 DOR: UNKNOWN. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19941118 ↗
• InjuryMar 13, 2023Adverse 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. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2022 DOR: (B)(6) 2023 AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16529528 ↗
• MalfunctionMar 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE SURGEON BROACHED TO A 3 AND WHEN HE IMPLANTED THE STEM HE FELT IT WENT IN TOO EASY COMPARED TO BROACH. HE BROACHED TO A 4 AND IMPLANTED. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16462004 ↗
• MalfunctionDec 27, 2022Defective Device; Device-Device Incompatibility; Defective Device; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON IS CONCERNED THAT THE RELATIONSHIP BETWEEN THE ACTIS BROACHES (SIZE 3 IN THIS INSTANCE) AND REAL IMPLANTS (SIZE 3 HI IN THIS INSTANCE) IS CAUSING THE REAL STEM TO SIT MORE PROUD THAN EXPECTED AFTER SEATING THE FINAL BROACH; SURGEON IS CONCERNED THAT THE POROUS AND/OR HA COATING ON THE REAL IMPLANTS HAS BEEN CHANGE, CAUSING THE REAL STEMS TO SIT MORE PROUD THAN THE TYPICAL PRESS-FIT HAS BEEN EXPERIENCED SINCE USING THE ACTIS STEM FROM ITS FIRST AVAILABILITY. SURGEON WOULD LIKE A CORRESPONDENCE FROM AN ACTIS ENGINEER ASSURING HIM THAT THERE HAVE BEEN NOT CHANGES TO THE COATING ON THE ACTIS STEMS AND THAT THERE ARE NO REPORTED ISSUES WITH THE RELATIONSHIP BETWEEN THE ACTIS BROACH AND CORRESPONDING STEM. IN ADDITION, HE WANTS TO KNOW IF SPECIFICATIONS/TOLERANCES OF POROUS/HA COATING HAVE NOT CHANGED, HAS THERE BEEN A CHANGE IN THE FACILITY WHERE ACTIS STEMS ARE MANUFACTURED OR LOCATION, IF DIFFERENT, WHERE POROUS/HA COATING IS APPLIED TO STEM? NO SURGICAL DELAY. DOE: (B)(6) 2022. AFFECTED SIDE: LEFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051694 ↗
• InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED HIP. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15573520 ↗
• InjuryOct 7, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO THE STEM BEING LOOSE AND CALCAR FRACTURE. LOOSENING INTERFACE AT BONE TO IMPLANT. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 15561958 ↗
• InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON THOUGHT PATIENT WAS INFECTED. HEAD AND LINER EXCHANGE WERE PERFORMED. STEM CAME OUT WHEN HEAD WAS EXTRACTED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14978691 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FEMUR FRACTURE. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 13860153 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A PERIPROSTHETIC FRACTURE. DOI: UNKNOWN DOR: (B)(6) 2021 AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Limb Fracture

  MAUDE report 11827815 ↗
• MalfunctionFeb 4, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11278449 ↗
• MalfunctionFeb 2, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  J&J BOXES WERE SMASHED AND RIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11265912 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEG WAS TOO LONG, SO THE STEM AND HEAD WERE REMOVED AND REPLACED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10489237 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO UNSTABLE HIP. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Joint Disorder; No Code Available

  MAUDE report 9498112 ↗