SELF CENTERING 1035-41-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295003311), received between Dec 19, 2018 and May 30, 2025 — classified as 2 deaths, 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (6 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.

• InjuryMay 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED POST HEMI ARTHROPLASTY. PATIENT HAS SEVERE DEMENTIA AND SURGEON CHOSE TO CONVERT TO A CONSTRAINED CUP AND LINER WITH A COMPETITIVE COMPANY, AS STAFF DO NOT OFFER ONE AS SMALL AS PATIENT NEEDED. NO PATIENT HARM OR DELAY WAS NOTED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22115939 ↗
• MalfunctionAug 4, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A HEMI HIP ARTHROPLASTY CASE. A 41 BIPOLAR HEAD IMPLANT FAILED DURING ASSEMBLY. THE LINER WOULD NOT PROPERLY SEAT IN THE OUTER SHELL AND THE 28 MM HEAD SAT PROUD WITHIN THE LINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17463578 ↗
• MalfunctionFeb 16, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A BIPOLAR HIP SURGERY, IMPLANTS WERE OPENED WHEN REGULATED. THE TECH ASSEMBLED THE FEMORAL HEAD WITH THE BIPOLAR HEAD AND NOTED THAT THE ARTICULATION SECOND MORE DIFFICULT THAN USUAL. DEFECTIVE IMPLANTS WERE NOT IMPLANTED OR IN CONTACT WITH PATIENT AT ANY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386514 ↗
• MalfunctionJan 13, 2023Difficult to Insert; Difficult to Insert

  DR. FELT THAT THE BIPOLAR LINER AND SHELL HAD TOO MUCH LAXITY. IT WAS UNUSUAL FOR THE BIPOLAR CUP. HENCE, DECIDED TO USE A NEW BIPOLAR CUP. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157546 ↗
• 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 16122094 ↗
• MalfunctionNov 17, 2022Fracture; Fracture

  IT WAS REPORTED AS BROKEN LINER SELF-CENTERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815505 ↗
• MalfunctionJun 28, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT 41MM BIPOLAR SHELL WAS USED DURING IMPLANTING. UPON SECURING THE BIPOLAR SHELL TO THE FEMORAL HEAD IMPLANT, SURGEON NOTICED A GAP BETWEEN THESE 2 IMPLANTS WHICH DOES NOT TYPICALLY HAPPEN IN OTHER BIPOLAR CASES. SURGEON DECIDED TO TEST THE SAME USING A BIPOLAR SHELL OF A DIFFERENT SIZE (42MM), AND A DIFFERENT FEMORAL HEAD IMPLANT OF THE SAME SIZE. THE SAME TEST WAS CONDUCTED UPON IMPLANTING AND THE BIPOLAR SHELL STILL LIFTED OFF THE FEMORAL HEAD IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14842734 ↗
• MalfunctionJul 8, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE 41MM BIPOLAR HEAD POLY INSERT WAS LOOSE AND HAD TOO MUCH TOGGLE WITH THE OUTER METAL SHELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12134265 ↗
• InjuryApr 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY. AFFECTED SIDE WAS THE RIGHT HIP.

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

  MAUDE report 11601856 ↗
• InjuryFeb 2, 2021Fracture; Fracture

  IT WAS REPORTED THAT THIS IS THE 2ND REVISION FOR THE PATIENT. SAME ISSUE. SIZE 41 BIPOLAR LOCKING RING BROKE FROM IMPINGEMENT. THE PATIENT HAS A FUSED KNEE ON THE SAME LEG. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 11266678 ↗
• InjuryJan 12, 2021Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO BI-POLAR LOCKING RING BROKE. HIP DISLOCATED. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11155174 ↗
• InjuryApr 10, 2019Difficult to Insert; Appropriate Device Problem Term/Code Not Available; Difficult to Insert; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A 28 HEAD MAY HAVE NOT BEEN ARTICULATING IN THE BIPOLAR HEAD LIKE NORMAL. UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available

  MAUDE report 8501042 ↗
• DeathFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMMUNICATION RECEIVED. A DAUGHTER OF A PATIENT FROM (B)(6), CALLED UP REGARDING THE HIP REPLACEMENT COMPENSATION, IN REFERENCE TO THE NEWS SHE READ IN THE NEWSPAPER. SHE SAID THAT HER MOTHER HAD UNDERGONE A SURGERY OF TOTAL HIP REPLACEMENT IN THE YEAR 2014 AT A HOSPITAL IN (B)(6), AND IN (B)(6) 2015 HER MOTHER PASSED AWAY. THUS, SHE WANTS TO KNOW THE PROCEDURE TO CLAIM THE COMPENSATION AMOUNT.

  Patient problems: Death; Pain

  MAUDE report 8314629 ↗
• DeathDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS A RIGHT EXTRA CAPSULAR NECK OF FEMUR FRACTURE AND PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8179397 ↗