SELF CENTERING 1035-43-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295003335), received between Sep 5, 2017 and Jan 26, 2026 — classified as 18 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING THE SURGERY, THE DEVICE WAS ABNORMALLY LOOSE. THERE IS CLICKING SOUND WITH CERAMIC HEAD AFTER IMPLANTATION. THEN THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THE SURGERY WAS DELAYED FOR ABOUT THIRTY MINUTES. THE PATIENT IS CURRENTLY STABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183541 ↗
• MalfunctionSep 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INNER POLY WAS LOOSE INSIDE OF METAL SHELL. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOW SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964875 ↗
• MalfunctionAug 7, 2025Difficult to Insert; Difficult to Insert

  PATIENT WAS OPERATED ON FOR TRUE GARDEN IV CERVICAL FRACTURE OF THE RIGHT FEMORAL NECK; INDICATION FOR HEMIARTHROPLASTY BY ANTERIOR APPROACH. DURING AN INTERMEDIATE PROSTHESIS, THE RING OF THE CUP IMPLANT DID NOT FIT CORRECTLY; THE POLYETHYLENE DID NOT APPEAR TO BE WELL FLAT. THE SURGEON TOOK ANOTHER IMPLANT OF THE SAME SIZE. NO CLINICAL CONSEQUENCES, THIRTY SECONDS LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738844 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A LEFT HEMI HIP THAT IS INFECTED. THE SURGEON DID A WASHOUT AND HEAD EXCHANGE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21324435 ↗
• InjuryJan 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR DISLOCATION. THE SURGEON NEEDED A SHORTER HEAD BALL SIZE. DOI: (B)(6)2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21110513 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO WASH OUT FOR INFECTION. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- ON (B)(6) 2024, DOR- ON (B)(6) 2024, AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19460071 ↗
• MalfunctionDec 7, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHEN COMBINED WITH THE HEAD DURING SURGERY, A STRANGE SOUND IS HEARD AND IT DOES NOT FIT WELL. EVEN WHEN IT WAS CONNECTED, IT FELT LIKE THE HEAD WAS RAISED INSIDE THE CUP BECAUSE IT WAS NOT PROPERLY CONNECTED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287280 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD WASH OUT WITH HEAD EXCHANGE. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN . DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18074390 ↗
• MalfunctionAug 30, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THERE WAS A GAP BETWEEN THE POLYETHYLENE AND THE DOME.

  Patient problems: Insufficient Information

  MAUDE report 17656378 ↗
• InjuryAug 15, 2023Fracture; Fracture

  HCP IS REPORTING A REVISION OF A DUO-HEAD HIP-INLAY BECAUSE OF FRACTURE. DOI: MAY 9, 2023. DOE:(B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17549916 ↗
• InjuryMar 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT BIPOLAR HAD MIGRATED AND THE HIP DISLOCATED FROM THE BIPOLAR. THE PATIENT WAS INFECTED. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 16609222 ↗
• MalfunctionFeb 27, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHEN ASSEMBLING THE BALL HEAD INTO BIPOLAR HEAD, SURGEON FOLLOWED AS PER MANUAL AND TOOK OUT POLY TO PLACE INNER BALL. HE THEN PLACED THE POLY BACK INTO OUTER HEAD AND FOUND THAT THE POLY HAD A BIT OF WOBBLE AND WAS WORRIED THAT IT DID NOT SEAT PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16443169 ↗
• 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 16121976 ↗
• MalfunctionFeb 25, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE DR. INSERTED THE HEAD IN THE POLYETHYLENE, INTRODUCTION INTO THE METAL DOME, A MANEUVER THAT IS DIFFICULT UNLIKE OTHER TIMES. THERE REMAINS A SLIGHT STEP OF THE POLYETHYLENE COMPARED TO THE METAL RHYME. THE HEAD INSTEAD CONTINUES TO ROTATE CORRECTLY. USE OF ANOTHER SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13599876 ↗
• MalfunctionOct 8, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHEN ASSEMBLING BIPOLAR SELF CENTERING, THE INNER RING (PE ONE, ALREADY ASSEMBLED WITH THE FEMORAL HEAD) DID NOT SECURELY LOCK TO THE OUTER RING (METAL ONE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12599121 ↗
• MalfunctionSep 27, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE BIPOLAR HEAD WAS DEFECTIVE WHEN OPENED STERILE ONTO FILED. THE LOCKING MECHANISM BETWEEN THE POLY AND THE SHELL DID NOT SEAT. POLY WOULD SLIDE AND MOVE WITHIN METAL HEAD. DR. DID NOT FEEL COMFORTABLE USING. ORIGINAL IMPLANT DATE UNKNOWN. NO SURGICAL DELAY. DOI: UNKNOWN, DOE: (B)(6) 2021, AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12532358 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 11273322 ↗
• InjuryJan 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT REVISED DUE TO DISLOCATION, A NEW HEAD AND BIPOLAR WERE IMPLANTED. DOI: (B)(6) 2020: DOR: (B)(6) 2020: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11124124 ↗
• InjuryJan 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS CONVERTED TO A TOTAL HIP BECAUSE OF DISLOCATION. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11123175 ↗
• InjuryJul 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  POST-OP DISLOCATION. IT WAS REPORTED THAT THE PATIENT WAS GIVEN THE HALF HIP REPLACEMENT ON (B)(6) 2020. AFTER LEAVING THE HOSPITAL,THE PATIENT HAD A FALL, WHICH RESULT THE HEAD DETACHED FROM THE LINER AS THE X-RAY PHOTOS SHOW. THE PATIENT WAS GIVEN TOTAL HIP REPLACEMENT OPERATION ON (B)(6) 2020. THE PATIENT IS STABLE AND IN HOSPITAL NOW. THE SURGEON THINKS IT IS NORMAL THAT DISLOCATION AFTER FALLING, BUT IT IS ABNORMAL THAT THE HEAD WAS OUT OF LINER AFTER FALLING, SO HE SUSPECT LINER'S LOCK MECHANISM DID NOT FUNCTION, WITH SOME QUALITY ISSUE, SO THE LINER COULD NOT LOCK/HOLD THE HEAD, AND ALSO HAS SOME CONCERNS ABOUT THE LINER WAS NOT CONNECT WITH CUP CLOSELY, IF THE CUP AND LINER ARE DESIGNED WITH THIS NORMAL GAP OR IT IS ABNORMAL.

  Patient problems: Fall; Joint Dislocation; No Code Available

  MAUDE report 10253570 ↗
• InjuryMay 28, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10097481 ↗
• MalfunctionMay 18, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT AFTER THE SCRUB TECH ASSEMBLED THE 43MM BIPOLAR SHELL, SHE PRESSED ON THE POLY LINER AND NOTICED THAT IT WAS ROCKING BACK AND FORTH WITHIN THE SHELL. A NEW 43MM BIPOLAR SHELL WAS OPENED AND IMPLANTED, INSTEAD. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10067024 ↗
• MalfunctionJul 8, 2019Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT THERE WAS A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8768438 ↗
• InjuryJan 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8253332 ↗
• MalfunctionOct 16, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  METAL HEAD WAS LOOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7969645 ↗