SELF CENTERING 1035-46-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10603295003366), received between Jul 14, 2017 and Apr 17, 2026 — classified as 50 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (20 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 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT REMOVED COMPONENTS DUE TO FX, DISLOCATION, AND NON COMPLIANCE. DOI (B)(6) 2026. DOR-UNKNOWN. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24915581 ↗
• InjuryApr 3, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR CHRONIC DISLOCATION. PATIENT WAS REVISED TO A TOTAL HIP FOR DISLOCATING. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24775280 ↗
• MalfunctionFeb 12, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A THREAD-LIKE FOREIGN MATERIAL IS OBSERVED ON THE SURFACE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322177 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE REPLACED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24189699 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BIPOLAR REMOVED BECAUSE OF INFECTION. AFFECTED SIDE-LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23716313 ↗
• InjuryOct 24, 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 FIRST STAGE INFECTION. SURGEON WASHED OUT AND SWAP THE BIPOLAR HEAD. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23378182 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD RIGHT HIP PAIN WITH SUSPECTED INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22560468 ↗
• InjuryJul 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED OF HEMI TO TOTAL FOR DISLOCATION CONVERSION. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22530732 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ACTIS STEM, BIPOLAR HEAD AND ARTICUL/EZE HEAD WERE REMOVED BECAUSE OF INFECTION. ALL IMPLANTS WERE REMOVED WITHOUT ANY ISSUES. THERE WAS NO DELAY. DOI: (B)(6), 2025. DOR: (B)(6), 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22420857 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON PERFORMED A HEAD EXCHANGE IN CONJUNCTION WITH A THOROUGH I&D. THERE WAS NO EVIDENCE OF INFECTION BUT MULTIPLE CULTURES WERE SENT AS A PRECAUTION. NO HARM AND NO DELAY WERE NOTED. THERE WAS NO ALLEGATION AGAINST ANY COMPONENT AS THEY WERE PERFORMING AS EXPECTED. DOI: (B)(6) 2025 , DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22415302 ↗
• InjuryMay 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. A 28 HEAD AND BIPOLAR HEAD WERE REVISED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22017240 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21859181 ↗
• InjuryMar 18, 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 INFECTION/ I&D. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21632460 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO BEING UNSTABLE. HEAD WAS EXPLANTED AND WAS REPLACED WITH DUAL MOBILITY. THE SURGICAL DELAY IS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 21267583 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INSTABILITY. THERE WAS NO DELAYS, NO BROKEN INSTRUMENTS, NO HARM TO PATIENT. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Joint Laxity

  MAUDE report 20748330 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY REPORTED. THE REASON FOR WASHOUT AND REVISION WAS BECAUSE THE PATIENT'S INCISION WAS RED, IRRITATED AND DRAINING.

  Patient problems: Erythema; Fluid Discharge; Skin Inflammation/ Irritation

  MAUDE report 20506419 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 20369392 ↗
• InjuryAug 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR HEMI ARTHROPLASTY DONE AT HOSPITAL IN 2022. PATIENT HAD BEEN DISLOCATING SO THE BIPOLAR HEAD AND 28 MM BALL WERE REMOVED AND REPLACED WITH COMPETITIVE IMPLANTS. DOI: (B)(6) 2022. DOR:(B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20079532 ↗
• InjuryJun 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED: -THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Dislocation

  MAUDE report 19528632 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. PATIENT¿S HIP HAS BECOME INFECTED, AND SURGEON FEELS THEY WOULD BENEFIT FROM A WASHOUT OF THE HIP, WITH AN EXCHANGE OF THE BIPOLAR PROSTHESIS. THE ORIGINAL BIPOLAR IMPLANT WAS REMOVED, THE HIP WAS THOROUGHLY WASHED OUT, AND A NEW BIPOLAR COMPONENT WAS OPENED AND IMPLANTED. THERE WERE NO ADVERSE EVENTS OR DELAYS THAT TOOK PLACE. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 18443547 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. HEAD AND BIPOLAR HEAD WERE EXCHANGED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18434001 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS POST OP FROM CASE ON (B)(6) 23. PATIENT IS IN LIVER FAILURE AND CONTINUES TO BLEED. INFECTION RELATED TO LIVER FAILURE. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 17940701 ↗
• InjuryFeb 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED FOR DISLOCATION. EXPLANTED THE BIPOLAR HEAD AND 28 ARTICULEZE HEAD. IMPLANT A PINNACLE CUP, SCREWS, NEUTRAL LINER AND NEW 32 +9 ARTICULEZE HEAD. NO INJURY TO THE PATIENT. NO DELAY IN SURGERY. THIS WAS THE LEFT HIP. ORIGINAL DOS WAS (B)(6) 2021. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES. FACILITY NAME OF ORIGINAL IMPLANT : (B)(6) MEDICAL CENTER. WAS DEVICE EXPLANTED? TRUE. HARDWARE/EXPLANT REMOVAL DUE TO: DISLOCATION. DID PATIENT REQUIRE REVISION SURGERY? TRUE. IF YES, DATE OF REVISION SURGERY. (B)(6) 2023. REASON FOR REVISION SURGERY. DISLOCATION. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? DISLOCATION. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(6). DEVICE PROPERTY OF: PATIENT. DEVICE IN POSSESSION OF: NONE, (B)(6). DEVICE PROP

  Patient problems: Joint Dislocation

  MAUDE report 16304914 ↗
• MalfunctionJan 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT SHELLS WILL NOT STAY ON HEAD.

  Patient problems: Insufficient Information

  MAUDE report 16121934 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS HAVING GROIN PAIN. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15502531 ↗