ACTIS 101012100Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295380627), received between Nov 9, 2017 and Jul 14, 2023 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CAME IN WITH A TYPE B FRACTURE. IMPLANT WAS REMOVED AND A ARCOS STEM WAS IMPLANTED. A NEW LINER WAS IMPLANTED AS WELL. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 17325754 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED HIP. THE COMPONENTS WERE REMOVED AND WASHED OUT THE HIP. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16512121 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 PATIENT HAD LEFT HIP PAIN IN HIP AND LOUD NOISE. ON (B)(6) 2019 PATIENT HAD FEMUR FRACTURE AND BROKEN STEEL PLATE (SYNTHES). THEN THE PATIENT WAS REVISED ON (B)(6) 2019. PATIENT HAD UNDERGONE A TOTAL HIP ARTHROPLASTY REVISION AND OPEN REDUCTION INTERNAL FIXATION DUE TO FAILURE ORIF LEFT THA PERI-PROSTHETIC FRACTURE(NO INFECTION NOTED). THEY HAD MANAGED TO SUPPORT THE FRACTURE WITH SYNTHES TRAUMA DEVICES AND REPLACED ONLY THE STEM WITH A COMPETITOR(STRYKER). DOI: (B)(6) 2019: DOR: (B)(6) 2019; LEFT HIP 2ND COMPLAINT.

  Patient problems: Limb Fracture; Pain

  MAUDE report 15637902 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE SAME OF SURGERY. THEY WERE NOT SURE IF THERE WAS A CRACK DURING PROCEDURE THAT WENT UNNOTICED OR IF IT OCCURRED POST OP IN THE HOSPITAL. PATIENT WAS REVISED WITH A RECLAIM STEM. THERE WAS LOOSENING EXPERIENCED AND THE LOOSENING INTERFACE WAS NON-CEMENTED. AND THERE WAS NO DELAY IN SURGERY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 15209253 ↗
• MalfunctionMay 12, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE NURSE NOTICED A HAIR ON PLASTIC LID OF PACKAGING AFTER OPENING IMPLANT. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14373838 ↗
• InjuryJan 6, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. A REVISION STEM WAS IMPLANTED. DOI: (B)(6) 2020. DOR: (B)(6) 2020; (LEFT HIP).

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 11123921 ↗
• InjurySep 11, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT FELL A FEW WEEKS AFTER SURGERY AND FRACTURED HIS FEMUR. FEMORAL STEM WAS REMOVED, FEMUR PREPPED FOR LONGER STEM AND CABLED. LINER AND HEAD BALL ALSO REPLACED. IT WAS ALSO REPORTED THAT THE STEM WAS LOOSE AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020. DOR: (B)(6) 2020. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s); Fall; Inadequate Osseointegration; No Code Available

  MAUDE report 10522217 ↗
• MalfunctionMar 6, 2020Loss of Osseointegration; Loss of Osseointegration

  THE SURGEON STATED THAT THE PATIENT COMPLAINED OF PAIN. RADIOLUCENT LINES WERE PRESENT AROUND THE FEMORAL STEM IN X-RAY. THE SURGEON BELIEVED THAT THE STEM WAS LOOSE AND PLANNED TO REVISE IF SYMPTOMS PERSIST. DOI: (B)(6) 2019. DOR: NOT YET REVISED. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9801801 ↗
• MalfunctionDec 12, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT WAS HAVING A LEFT TOTAL HIP. DURING THE SURGERY, THE SURGEON BROACHED TO A 10 ACTIS STEM. THE BROACH WAS VERY TIGHT AND ROTATIONALLY STABLE. WHEN THE REAL IMPLANT WAS INSERTED, IT SANK ALL THE WAY TO THE COLLAR WITH NO PRESSFIT. THE SURGEON INSERTED THE STEM WITH HIS FINGERS AND IT SEATED FULLY AND WAS LOOSE. THE SURGEON WENT UP ONE BROACH SIZE AND IMPLANTED THE NEXT SIZE STEM AND GOT MINIMAL PRESSFIT, BUT THE STEM SEEMED TO BE STABLE AND WAS RETAINED. THE PRESSFIT OF THESE STEMS IS NOT ENOUGH TO BE SOLID. DOE: (B)(6) 2019. LEFT HIP.

  Patient problems: Not Applicable

  MAUDE report 9459841 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAS A RIGHT TOTAL HIP DONE BY SURGEON. THE PATIENT IS INFECTED, SO THE SURGEON REMOVED THE COMPONENTS AND IMPLANTED TEMPORARY PARTS. ALL PIECES WERE WELL FIXED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9310514 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE PATIENT HAS NOW BEEN REVISED. THE REVISION WAS DUE TO FURTHER FRACTURE OF THE INITIAL FRACTURE OF THE FEMORAL BONE. THE STEM COMPONENT HAD SUBSIDED AS WELL AND THUS THE STEM AND HEAD WERE REMOVED AND REVISED.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Discomfort; Hip Fracture; Limb Fracture; No Code Available; Pain

  MAUDE report 8745690 ↗
• MalfunctionMar 22, 2019Fitting Problem; Appropriate Device Problem Term/Code Not Available; Fitting Problem; Appropriate Device Problem Term/Code Not Available

  BROACH AND IMPLANT DID NOT SEEM TO MATCH. CUSTOMER REFERENCE/PO/SERVICE: (B)(4), WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 10-15, ACTION TAKEN WHEN EVENT OCCURRED? ALTERNATIVE IMPLANT USED., WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, 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, IP-00512191: DEVICE PROPERTY OF? NONE, DEVICE IN POSSESSION OF? SUBMITTER. IP-00512192: 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: Not Applicable

  MAUDE report 8444664 ↗
• InjuryOct 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON BROUGHT THE PATIENT IN TO ASPIRATE HIS NATIVE HIP (RIGHT HIP) TO CHECK FOR INFECTION. UPON OPENING THE OTHER SIDE, THE LEFT HIP, HE FOUND THE JOINT TO BE INFECTED. HE DECIDED THE BEST THING TO DO WAS REMOVE ALL IMPLANTS, CLEAN OUT THE JOINT AND RE-IMPLANT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7962530 ↗
• MalfunctionNov 9, 2017Delivered as Unsterile Product; Device Contamination with Chemical or Other Material; Delivered as Unsterile Product; Device Contamination with Chemical or Other Material

  DER STATES THAT UPON OPENING THE IMPLANT, THE SCRUB TECH NOTICED THAT THERE WAS A HAIR ON THE BLUE PACKAGING THAT ENCASES THE STEM. IT WAS ALSO REPORTED THAT ANOTHER STEM WAS READILY AVAILABLE AND THE CONTAMINATED STEM WAS PASSED OFF. IT WAS BELIEVED THAT IT WAS CONTAMINATED DURING PACKAGING PROCESS.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7013342 ↗