SELF CENTERING 1035-56-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295003465), received between Apr 6, 2018 and Feb 27, 2026 — classified as 14 injuries, 1 malfunction.

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

• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED RIGHT HIP. BIPOLAR HEAD AND 28 HEAD EXCHANGE. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24472991 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS INFECTED AND DOCTOR PERFORMED I&D AND CHANGED BIPOLAR HEAD. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23864855 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO PAIN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 22793289 ↗
• InjuryJun 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A PROSTALAC SPACER PLACED BUT DISLOCATED POSTOPERATIVELY. THE DOCTOR BROUGHT THE PATIENT BACK TO REVISE. HE BELIEVED THAT THE VERSION AND OFFSET NEEDED TO BE CHANGED. THE PROSTALAC STEM WAS REMOVED. A NEW HIGH OFFSET SIZE 1 PROSTALAC WAS IMPLANTED WITH A 56MM BIPOLAR HEAD AND 28 +8.5 FEMORAL HEAD. AFFECTED SIDE : LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22344760 ↗
• InjuryMar 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE PATIENT HAD FELL AND DISLOCATED THE HIP. THE SURGEON DECIDED TO REMOVE THE BIPOLAR SHELL AND REPLACE WITH A CUP AND CONSTRAINED LINER. THERE WAS NO PROBLEM WITH OUR IMPLANTS AND THERE WAS NO EXTENDED TIME AS WELL. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 21608261 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS UNSTABLE. THE STEM VERSION AND OFFSET WERE CHANGED. NO DELAYS. NO HARM TO PATIENT. NO FURTHER INFORMATION IS AVAILABLE. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 20344157 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO UNSTABLE HIP. NO POLY WEAR. DO NOT KNOW CAUSE OF INSTABILITY. NO DELAY AND NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 20281922 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: PRIMARY DATE UNKNOWN. NO DELAY, INSTABILITY, NO HARM.

  Patient problems: Joint Laxity

  MAUDE report 20156943 ↗
• InjuryJan 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO DISLOCATION. THE HIP COULD NOT BE REDUCED UNDER SEDATION, SO THE SURGEON PERFORMED AN OPEN REDUCTION PROCEDURE. DURING THE PROCEDURE, THE SURGEON REMOVED AND REPLACED THE PATIENT'S ORIGINAL BI-POLAR HEAD CONSTRUCT WITH A LONGER UNI POLAR HEAD CONSTRUCT, TO INCREASE THE PATIENT'S LEG LENGTH AND FEMORAL OFFSET FOR INCREASED STABILITY. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Laxity; Physical Asymmetry

  MAUDE report 18565040 ↗
• InjuryAug 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO BIPOLAR LINER WAS DISASSOCIATING FROM METAL SHELL DURING FINAL RANGE OF MOTION TEST. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 17481808 ↗
• InjuryJan 6, 2022Naturally Worn; Naturally Worn

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED WAS DUE TO PAINFUL HEMI ARTHROPLASTY WITH ARTHRITIS OF LEFT HIP AND OBVIOUS WEAR OF HIS BIPOLAR IMPLANT. DOI: (B)(6) 2017, DOR: (B)(6) 2019, LEFT HIP 2ND REVISION. PLEASE SEE (B)(4) LEFT HIP 1ST REVISION.

  Patient problems: Pain

  MAUDE report 13175264 ↗
• InjuryOct 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION, POSTERIOR ACETABULAR WALL COLLAPSE . GIRDLESTONE PROCEDURE. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Bone Fracture(s); Joint Dislocation; No Code Available

  MAUDE report 9209379 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION AND BONE FRACTURE AFTER FIRST REVISION. DOI: (B)(6) 2014; DOR: (B)(6) 2014; (LEFT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8374029 ↗
• InjuryNov 8, 2018Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  REVISED DUE TO DISASSOCIATION.

  Patient problems: Joint Dislocation

  MAUDE report 8051595 ↗
• MalfunctionApr 6, 2018Device Expiration Issue; Device Expiration Issue

  DER STATES A BI-POLAR HEAD WAS IMPLANTED IN THIS PATIENT THAT HAD AN EXPIRATION DATE OF (B)(6) 2018. SALES REP MISSED THE DATE, AS DID THE CIRCULATOR AND THE SCRUB NURSE. I WAS JUST NOTIFIED ABOUT THE MISTAKE. THE FACILITY IS REQUESTING A RESPONSE LETTER, STATING THE IMPLANT AND PATIENT ARE SAFE. DOE: (B)(6) 2018 UNKNOWN AFFECTED SIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7402790 ↗