ACTIS 101011030Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10603295380436), received between Dec 20, 2017 and Jun 8, 2026 — classified as 31 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (3 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 38 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTS WITH PERIPROSTHETIC FEMUR FRACTURE STATUS POST PRIMARY TOTAL HIP REPLACEMENT. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 25432059 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BROKE THEIR FEMUR. IT WAS REVISED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 24845166 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VOLUNTARY REPORT WAS RECEIVED (MW5178947). PATIENT WAS ON A TWO STEP STOOL, REACHED DOWN TO PICK UP SOMETHING ON THE FLOOR, AND IMMEDIATELY HEARD AUDIBLE. WITH EACH STEP IT WAS NOTED THE HIP WAS MAKING NOISE, HOWEVER, THE NOISE LESSENED AFTER A WEEK AND WAS HEARD DURING SPECIFIC MOVEMENTS. PATIENT THEN EXPERIENCED JOLTS AND STATED IN RETROSPECT THE AUDIBLE SOUNDS PROBABLY STARTED 4-6 MONTHS PRIOR TO (B)(6) CLINIC APPT. PATIENT SCHEDULED AN APPOINTMENT AND X-RAY SHOWED A CATASTROPHIC FAILURE OF LEFT HIP PROSTHESIS. METALLOSIS WAS NOTED WHEN SURGERY WAS DONE IN 2024. TWO REVISION SURGERIES WERE COMPLETED: 2024: LEFT HIP REVISION SURGERY. PATIENT EXPERIENCED SIGNIFICANT LEFT HIP AND LEFT FOOT PAIN, WALKING WITH A STROLLER. HEADBALL AND LINER WAS REPLACED. SIGNIFICANT METALLOSIS NOTED. ( 2024 SECOND HIP REVISION SURGERY. ACETABULAR CUP, HEADBALL AND LINER REPLACED METALLOSIS NOTED. IT WAS BELIEVED THAT THE BACK SIDE WAS DEFECTIVE. PATIENT WAS WALKING WITH A CANE/STROLLER. ORTHOPEDIC SURGEON SENT PROSTHESIS INTO DEPUY FOR REVIEW. PATIENT HAD CHEMO AND RADIATION IN 2024. PATIENT ALSO HAD CELLULITIS DIX OF LEFT FOOT. CURRENTLY, THERE IS LEG LENGTH DISCREPANCY. WALKING LONG

  Patient problems: Ambulation or Postural Difficulties; Cellulitis; Discomfort; Foreign Body Reaction; Pain; Physical Asymmetry

  MAUDE report 23866357 ↗
• MalfunctionDec 8, 2025Device Damaged Prior to Receipt by User; Device Contaminated During Manufacture or Shipping; Device Damaged Prior to Receipt by User; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT UPON OPENING THE PLASTIC SEALED AND UNDAMAGED CARDBOARD BOX, IT WAS REALIZED THAT THE HARD PLASTIC SHELL HOUSING WAS CRACKED AND THE STEM CONTAMINATED. NO VISIBLE SIGNS OF DAMAGE TO THE OUTER CARDBOARD BOX TO SUGGEST MISHANDLING DURING SHIPPING/HANDLING. DOE: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23746151 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH INFECTED HIP 2 + YEARS POST THA. ALL WELL FIXED COMPONENTS WERE REMOVED AND A PROSTALAC WAS PLACED WITH NO DELAY NOR PATIENT HARM. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23584440 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON IMPLANTED A STANDARD OFFSET STEM, AND THEN WANTED TO CHANGE FOR MORE OFFSET. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23535288 ↗
• InjuryNov 3, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FX. FEMORAL STEM WAS LOOSE AT NON-CEMENTED INTERFACE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 23451945 ↗
• InjuryAug 20, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ACTIS STEM ASEPTIC SUBSIDENCE. IT WAS REPORTED THAT THIS WAS PROBABLY FROM UNDERSIZED FEMORAL COMPONENT. REVISION WAS PERFORMED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22848269 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, PATIENT HAD AN ARTHROPLASTY, DEPUY DUAL MOBILITY HIP PROSTHESIS WAS IMPLANTED. ON (B)(6) 2025, THE PATIENT HAD A REVISION DUE TO MECHANICAL FAILURE OF THE PROSTHETIC DEVICE. THE INDICATIONS FOR SURGERY INCLUDED PAIN, ELEVATED COBALT LEVEL OF 0.6 MCG/L WHICH WAS NOTED AS ¿SUGGESTING METAL WEAR OR CORROSION OF THE IMPLANTED DEVICE¿, AND IMPLANT FAILURE. IT SHOULD BE NOTED THAT LATERALITY OF THE HIP WAS NOT LISTED. THE "ELEVATED COBALT LEVEL" WAS BELOW REPORTABLE LIMITS. IT SHOULD ALSO BE NOTED THAT THERE WERE NO MEDICAL RECORDS PROVIDED THAT STATE THAT THERE WAS CORROSION OR METAL WEAR, NOR ANY ACTUAL MENTION OF IMPLANT FAILURE. DOI: (B)(6) 2022. DOR: (B)(6) 2025. LEFT HIP.

  Patient problems: Colitis; Cyst(s); Distress; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Inflammation; Necrosis; Pain; Skin Inflammation/ Irritation; Swelling/ Edema; Synovitis

  MAUDE report 22330838 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION OF TOTAL HIP FOR INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: ( B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21333247 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A POST-OP INFECTION OF A HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20664308 ↗
• InjuryOct 22, 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. DOI: (B)(6) 2024, DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20504302 ↗
• InjuryAug 28, 2024Adverse 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. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20088649 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 , THE PATIENT UNDERWENT A THA FOR OA WITH THE STEM AND THE HEAD. THE IMPLANTS WERE INSERTED AFTER TEMPORARY REDUCTION, AND FIXATION OF THE IMPLANT WAS WEAK FROM THE TIME OF TEMPORARY REDUCTION. THE X-RAY SHOWED THAT BONE CRACKS OCCURRED. THE IMPLANTS WERE REMOVED. THEN, A WIRE WAS WRAPPED AROUND THE DIAPHYSIS, AND OTHER COMPANY¿S CEMENT STEM WAS INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Limb Fracture

  MAUDE report 19478670 ↗
• MalfunctionApr 10, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  LINER PACKAGE OF IMPLANT CRACKED AND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19083686 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT GOT AN INFECTION POST SURGERY. THERE WAS NO ADDED TIME TO THE SURGERY. NO INSTRUMENTS WERE BROKEN DURING THE SURGERY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18926702 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH PAIN APPROXIMATELY 5 WEEKS POST OP. X-RAY REVEALED PERIPROSTHETIC FEMUR FRACTURE. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6), 2023. DOR: (B)(4), 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture; Pain

  MAUDE report 18256448 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO FALL AND PERI PROSTHETIC FRACTURE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 16386484 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD ORIGINAL SURGERY (B)(6) LEG LENGTHS DREW OUT AND APPEARED EQUAL ON TWO IMAGES - LLD WAS 3MM INITIALLY - AFTER EXAM / 12.21 PATIENT FEELS LEG LENGTHS OVER 3MM - SURGEON REVISED (B)(6) TO MATCH LENGTHS - 2 BROACH LOWERED 3RD LLS EXACT. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 16121305 ↗
• MalfunctionNov 30, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT SMALL WHITE DEBRIS WAS FOUND INSIDE THE INTERNAL PACKAGING AROUND THE STEM WHEN OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15886589 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND HAD A PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 15495949 ↗
• InjuryJun 22, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THE ACTIS STEM NEVER GREW IN. CAME OUT WITH A SINGLE MALLET TAP. THERE WAS A LOOSENING IN NON-CEMENTED INTERFACE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14774224 ↗
• InjuryJan 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED SECONDARY TO PATIENT FRACTURING FEMUR AFTER FALLING. HEAD, STEM, AND LINER WERE REPLACED. NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 13196149 ↗
• InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PERI PROSTHETIC FRACTURE. DOI: UNKNOWN. DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 12664629 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND FRACTURED THEIR FEMUR. DOCTOR REVISED THE STEM TO A COMPETITIVE MODULAR REVISION HIP STEM. AND CHANGED OUR HEAD BALL / LINER TO PINNACLE DUAL MOBILITY. DOI: (B)(6) 2021. DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 11655950 ↗