SELF CENTERING 1035-51-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295003410), received between Aug 9, 2018 and Jul 16, 2025 — classified as 24 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (15 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE POLY PORTION OF THE BIPOLAR HEAD, WHEN ASSEMBLED WITH THE 28MM CERAMIC HEAD, WAS NOT FULLY LOCKED IN AND COULD STILL TOGGLE BACK AND FORTH WITH THUMB PRESSURE. A NEW BIPOLAR HEAD WAS OPENED IN ITS PLACE AND THE PROCEDURE WAS CONCLUDED WITHOUT FURTHER DELAY OR COMPLICATION. THE HEAD IN QUESTION WAS NOT IMPLEMENTED. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22524243 ↗
• InjuryMay 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD PREVIOUS BIPOLAR HEMI WITH SUMMIT PF STEM. PATIENT HAS RECURRENT ANTERIOR INSTABILITY WITH DISLOCATION. THE SURGEON PERFORMED REVISION HEMI TO TOTAL ARTHROPLASTY. NO LOOSENING. STEM WELL FIXED. NO SURGEONS COMPLAINTS OF IMPLANT. NO CASE DELAY. NO BROKEN PIECES. NO OTHER INFORMATION KNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22104252 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND UNDERWENT REVISION SURGERY DUE TO PAIN. THE SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 21137203 ↗
• InjuryOct 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT ORIGINALLY DISLOCATED FOLLOWING A PREVIOUS FALL. ACETABULUM WAS BROKEN AND REQUIRED A CUP INSTEAD OF A BIPOLAR. DOI: UNKNOWN. DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s); Fall; Joint Dislocation

  MAUDE report 20506242 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED IMPLANT, ALL IMPLANTS REMOVED. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19478381 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BIPOLAR HEAD AND FEMORAL HEAD EXCHANGE DUE TO INFECTION. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19261155 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISING A HEMI AS RESULT OF AN INFECTION. KEPT STEM IN BUT REMOVED HEAD COMPONENTS AND PUT IN NEW. DOI- (B)(6) 2024; DOR-(B)(6) 2024; AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18940366 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION THAT DID NOT DISSIPATE WITH ORIGINAL WASH OUT. CAUSE OF INFECTION WAS BELIEVED TO BE IMPROPER WOUND CARE AT THEIR NURSING HOME, AS THE PATIENT IS PRACTICALLY IMMOBILE AND OFTEN TIMES SITS IN SOILED GARMENTS FOR A PERIOD OF TIME. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Loss of Range of Motion; Unspecified Infection

  MAUDE report 18039164 ↗
• InjuryApr 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 16732133 ↗
• 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 16121808 ↗
• InjuryMar 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD FALLEN AND DISLOCATED AT AN UNDEFINED TIME. SURGEON ELECTED TO CHANGE BIPOLAR HEAD TO 1 SIZE SMALLER. THERE IS NO ADDITIONAL INFORMATION REGARDING THIS EVENT. DOI: (B)(6) 2021 DOR: (B)(6) 2022 RIGHT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 13653363 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION SO THE SURGEON HAD WASHED OUT HIP AND CHANGED OUT BIPOLAR AND HEAD. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13651790 ↗
• InjuryFeb 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. LONGER NECK LENGTH WAS NEEDED. DOI: (B)(6) 2022, DOR: (B)(6) 2022, (UNKNOWN SIDE).

  Patient problems: Joint Dislocation

  MAUDE report 13497033 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED HIP. THE SURGEON REMOVED THE HIP HEMI IMPLANTS AND PERFORMED AN I&D AND PLACED NEW HIP HEMI IMPLANTS. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11516788 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HIP FRACTURE BACK IN (B)(6) OF 2016, WHERE DR. (B)(6) PERFORMED A HEMIARTHROPLASTY. ((B)(6) 2016) THE PATIENT HAS BEEN SUCCESSFULLY AMBULATING ON HEMI UNTIL RECENTLY. DUE TO SOME HIP PAIN, DR.(B)(6) BELIEVED THE PATIENT WOULD BENEFIT FROM HAVING THEIR HEMI CONVERTED TO A TOTAL. THE BIPOLAR AND 28MM HEAD WERE REMOVED, A COMPETITOR ACETABULAR COMPONENT WAS IMPLANTED, AND OUR FEMORAL HEAD WAS USED IN THE CONVERSION. THE SURGEON FOUND THIS CONVERSION TO BE SUCCESSFUL AND THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2016. DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 11163715 ↗
• InjuryJan 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED WHILE IN RECOVERY. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11140149 ↗
• InjuryNov 4, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO REMOVED BIPOLAR HEAD AND FEMORAL HEAD TO CONVERT TO A TOTAL HIP. POSSIBLE DISLOCATION. DOI: (B)(6) 2020. DOR: (B)(6) 2020; UNKNOWN HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10784899 ↗
• InjurySep 24, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED AND COULDN¿T BE REDUCED. PHYSICIAN WANTED TO REVISE HEAD TO MAKE JOINT MORE STABLE. STEM WAS NOT FIXATED SI DOCTOR THEN DECIDED TO USE A CEMENTED STEM. DOI: (B)(6) 2020. DOR: (B)(6) 2020. LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10580901 ↗
• InjuryJan 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD I&D AND HEAD EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9642773 ↗
• InjuryJan 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT FELL AND DISLOCATED HIS BIPOLAR HEMIARTHROPLASTY DONE BY THE SURGEON ON (B)(6) 2019 . HIP WAS REVISED TO A UNI-POLAR BY THE SURGEON. NO IMPLANTS WERE DEFECTIVE OR BROKEN. NO FURTHER INFORMATION AVAILABLE. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9592493 ↗
• InjurySep 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT FELL AND DISLOCATED THEIR HIP. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9006440 ↗
• InjurySep 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2019. DOR: UNKNOWN, LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8976433 ↗
• InjuryJul 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS DISLOCATING, THUS DR. DECIDED TO TAKE THE PATIENT TO SURGERY AND REVISE THE SIZE OF THE FEMORAL HEAD BY REMOVING THE ORIGINAL IMPLANT AND REPLACING IT WITH A SMALLER SIZE FEMORAL HEAD AND BI-POLAR HEAD. TWO IMPLANTS WERE TAKEN OUT AND BOTH IMPLANTS WERE REPLACED. DOI: UNKNOWN; DOR: (B)(4) 2019; UNKNOWN HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8807190 ↗
• InjuryJul 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT BIPOLAR HIP WAS CONVERTED TO TOTAL HIP BECAUSE OF CHRONIC DISLOCATION. DOI: UNKNOWN; DOR: (B)(6) 2019, (LEFT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8807014 ↗
• InjuryJan 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2018. DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8217343 ↗