SELF CENTERING 1035-55-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295003458), received between May 9, 2018 and Jul 30, 2026 — classified as 23 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had infection and needed to have everything removed to place an antibiotic spacer.DOI- (b)(6) 2026.DOR- (b)(6) 2026.Affected side-Right hip.

  Patient problems: Unspecified Infection

  MAUDE report 50093425 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND HAD OPENED INCISION. I&D HEAD AND BIPOLAR WERE EXCHANGED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 23337427 ↗
• MalfunctionJun 23, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INTERMEDIATE HIP PROSTHESIS PROCEDURE, THE DEFINITIVE ACETABULAR IMPLANT DOES NOT CLIP IN CORRECTLY; THERE IS PERSISTENT INSTABILITY BETWEEN (PE) AND THE METAL BACK. AFTER SEVERAL ASSEMBLY ATTEMPTS (WITH AND WITHOUT THE COCR HEAD) ON THE TABLE, THE SURGEON REQUESTED ANOTHER IMPLANT. NO CLINICAL CONSEQUENCES. THERE WAS A 5 MINUTES OF EXTENSION TO THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311407 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD AN EXISTING HEMI HIP WITH AN ACTIS STEM, 55MM BIPOLAR AND A 28MM +5 FEMORAL HEAD. THEY WERE BEING WASHED OUT FOR A SUSPECTED INFECTION. THE BIPOLAR HEAD AND 28MM FEMORAL HEAD WERE REMOVED AND REPLACED WITH NEW IMPLANTS OF THE SAME SIZE. ORIGINAL SURGICAL DATE WAS UNKNOWN. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22187042 ↗
• InjuryMay 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A HEMI DONE IN (B)(6) 2024. PATIENT FELL AND DISLOCATED THEIR HIP. PATIENT WENT TO GET IT REDUCED AT A HOSPITAL, AND UPON REDUCING, THE INNER 28MM HEAD DISCONNECTED FROM THE OUTER BIPOLAR SHELL. SURGEON TOOK OUT BOTH THE 28MM INNER HEAD AND THE 55 BIPOLAR HEAD AND PLACED NEW COMPONENTS OF THE SAME SIZES. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21972308 ↗
• InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A HEMI HIP ON (B)(6) 2024 USING A CEMENTED SUMMIT STEM, 55MM BIPOLAR AND 28 +1.5 FEMORAL HEAD. THE BIPOLAR SHELL/POLY HAD DISASSOCIATED FROM THE 28MM HEAD SO THE PATIENT WAS BEING REVISED. THE SURGEON EXPLANTED THE BIPOLAR SHELL/POLY AND REMOVED THE 28MM HEAD. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19119044 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT RETURNED TO SURGERY FOR INFECTION S/P HIP HEMI. ALL OF THE IMPLANTS WERE REMOVED AND THE WOUND WAS DEBRIDED AND IRRIGATED. NEW IMPLANTS WERE PLACED. THERE WERE NO DEFICIENCIES, DELAYS OR BROKEN INSTRUMENTS. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18364026 ↗
• InjuryJun 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED FOR DISLOCATING HIS BIPOLAR HIP APPROXIMATELY 2-3 TIMES SINCE (B)(6) 2023 PRIMARY IMPLANTATION. THE PATIENT UNDERWENT CONVERSION TO A MULTI-HOLE ACETABULAR CUP AND DUAL MOBILITY LINER ON (B)(6) 2023 FOR STABILITY. THERE IS NO HISTORY OF FALLS REPORTED. THERE WAS NO SURGICAL DELAY. DOI:(B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 17190112 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAS CONTINUED DRAINING POST HEMIARTHROPLASTY. THE SURGEON CHOSE TO DO AN I&D WITH COMPONENT EXCHANGE AND PLACEMENT OF ANTIBIOTIC BEADS. NO PATIENT HARM OCCURRED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 16860065 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED HIP BECAUSE OF PERIPROSTHETIC FRACTURE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 14468676 ↗
• InjuryAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION IRRIGATION AND DEBRIDEMENT WITH HEAD EXCHANGE. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (RIGHT HIP).

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

  MAUDE report 12289246 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT THERE WAS NO DELAY IN SURGERY AND NO BROKEN INSTRUMENTS. REVISION HAPPENED DUE TO INFECTION.

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

  MAUDE report 11832949 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2020. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 10983504 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10770424 ↗
• InjuryOct 19, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A DISLOCATION OF HIS HIP AFTER HEMI ON (B)(6) 2020. WHEN THE DISLOCATION HAPPENED IS UNCLEAR BUT IT HAS BEEN DISLOCATED FOR SOME TIME. A TOTAL HIP WAS PLACED AFTER THE HEMI IMPLANTS WERE REMOVED. DOI: (B)(6) 2020, DOR : (B)(6) 2020, LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10698094 ↗
• InjuryMay 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE NON AMBULATORY PATIENT THAT DISLOCATED AFTER HAVING A BIPOLAR HIP DONE ON (B)(6) 2020. SURGEON REMOVED A 55MM BIPOLAR HEAD. DOI: (B)(6) 2020. DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10087875 ↗
• InjuryMay 19, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT NO BROKEN INSTRUMENTS INVOLVED. AFFECTED SIDE LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10073472 ↗
• InjuryNov 27, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED FOR REPEATED DISLOCATION OF THEIR BIPOLAR HIP DONE BY CURRENT SURGEON'S PARTNER EARLIER THIS MONTH. PREVIOUS CEMENETED SUMMIT STEM WAS FOUND TO BE RETROVERTED, HOWEVER, SURGEON ELECTED TO LEAVE IT RATHER THAN REVISE IT DUE TO PATIENT AGE. DECISION WAS MADE TO CONVERT TO A TOTAL HIP AND CONSTRAINED LINER. NO FURTHER PATIENT INFORMATION AVAILABLE. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9383362 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION. REMOVED THE SUMMIT BASIC SZ 8 STEM AND 55MM BIPOLAR HEAD. AREA WASHED OUT. BROACH THE FEMUR WITH PROSTALAC BROACHES UP TO A SIZE 5. A SIZE 1 STANDARD OFFSET PROSTALAC STEM WAS OPENED AND CEMENT WAS THE CEMENT WERE PLACED IN THE SIZE 5 PROSTALAC MOLD. ONCE THE CEMENT WAS FULLY CURED, THE MOLD WAS TAKEN APART AND THE PROSTALAC STEM WAS IMPLANTED ALONG WITH A 56MM UNI POLAR HEAD AND +0 SLEEVE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9209262 ↗
• MalfunctionJul 1, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT BIPOLAR IMPLANT, THE LINER DOESN'T LOCK IN SOLID. YOU PRESS ON THE RIM OF THE LINER AND IT ROCKS BACK AND FORTH. WE DID NOT IMPLANT IT BECAUSE IT WASN'T LOCK IN SOLID. HE USED A DIFFERENT COMPANY. SURGICAL DELAYED OF 5 MINUTES. DOE: (B)(6) 2019, UNKNOWN AFFECTED SIDE.

  Patient problems: Not Applicable

  MAUDE report 8749019 ↗
• InjuryMar 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS HEMI HIP DISLOCATION. UPON EVALUATION, THE SURGEON DECIDED IT WAS BECAUSE OF OFFSET ISSUE. THE 13 STANDARD CORAIL STEM WAS REMOVED ALONG WITH THE BIPOLAR COMPONENT. IT WAS SWITCHED TO A KLA CORAIL STEM AND UNIPOLAR CONSTRUCT. DOI: (B)(6) 2019, DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8433135 ↗
• InjuryOct 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8023268 ↗
• InjuryJul 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 7726096 ↗
• InjuryJun 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7629439 ↗
• InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. DID WASHOUT AND REPLACED BIPOLAR HEAD. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7497958 ↗