SELF CENTERING 1035-40-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295003304), received between Jun 22, 2017 and Aug 3, 2026 — classified as 28 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (17 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50118785 ↗
• MalfunctionMar 31, 2026Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT THE DEVICE WAS DAMAGED AND THE POLYETHYLENE WAS NOT FIXED WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742817 ↗
• InjuryJul 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A CHRONIC INFECTION AND WAS EXPERIENCING DISLOCATION OF HER PREVIOUS CEMENTED SPACER CONSTRUCT WITH A BIPOLAR HEAD. CEMENTED LINER, BIPOLAR OUTER AND INNER HEADS REMOVED. PATIENT WAS WASHED OUT AND THEN PREPPED FOR A MULTIHOLE CUP, 10 DEGREE LINER AND HEAD. NO SURGICAL SLOW DOWNS, DELAYS OR ISSUES. PATIENT STABLE AFTER. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 19754257 ↗
• InjuryJun 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ABOUT 15 YEARS AGO THE PATIENT UNDERWENT A REVISION FOR UNKNOWN REASONS. A COMPETITOR LINER WAS CEMENTED INTO THE CUP AND A COMPETITOR BIPOLAR HEAD WAS PLACED. (B)(6) 2024: REVISION DUE TO DISASSOCIATION OF THE COMPETITOR BIPOLAR HEAD. INFECTION WAS QUESTIONED, BUT CULTURES WERE NEGATIVE. SAME SIZE BIPOLAR HEAD WAS PLACED, BUT DEPUY SYNTHES AT THIS TIME. (B)(6) 2024 (B)(4): REVISION DUE TO DISLOCATION OF THE DEPUY BIPOLAR HEAD WITH COMPETITOR LINER. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19469032 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION DONE BECAUSE OF INFECTION. DOI: (B)(6) 2018. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18463941 ↗
• 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 16122104 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR LEFT HIP REVISED DUE TO INSTABILITY. THE SURGEON REMOVED THE CUP, LINER, AND FEMORAL HEAD LEAVING THE FEMORAL STEM. A NEW CUP AND LINER FROM COMPETITOR WAS IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2022 AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 15233005 ↗
• MalfunctionMay 16, 2022Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT HOSPITAL LA FE HAS IMPLANTED A PRODUCT WITH AN EXPIRATION DATE THE 31/10/2021 ON 13/04/2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407750 ↗
• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORD RECEIVED. LITIGATION ALLEGES THAT THE PATIENT WAS DIAGNOSED WITH FIBROADIPOSE TISSUE AND FOCAL SYNOVIUM WITH CHRONIC INFLAMMATION, HEMOSIDEROSIS AND METALLOSIS. DOI: (B)(6) 2017. DOR: (B)(6) 2017. RIGHT HIP (SECOND REVISION).

  Patient problems: Foreign Body Reaction; Hematoma; Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain

  MAUDE report 14336366 ↗
• InjuryApr 5, 2022Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS PATIENT HAS A LEFT TOTAL HIP THAT IS A RECURRENT DISLOCATOR. THE SURGEON REVISED THE ZIMMER STEM AND CHANGED THE LINER IN OUR ACETABULUM. THE PINNACLE CUP IS WELL FIXED AND RETAINED. THE PATIENT IS STABLE NOW. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14014708 ↗
• InjuryOct 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PUT ON TO EXPLANT A HIP BALL , BIPOLAR SHELL AND A PINNACLE LINER BECAUSE OF INSTABILITY, AND REPLACE WITH A NEW HIP BALL AND A CONSTRAINED LINER. DURING THE PROCEDURE THE SURGEON EXPLANTED THE HIP BALL, BIPOLAR SHELL, AND PINNACLE LINER. THE SROM STEM AND PINNACLE CUP WERE LEFT IN SITU. A NEW 36MM SROM HIP BALL AND A 36MM X 56MM CONSTRAINED LINER WAS IMPLANTED. THE SURGEON WAS SATISFIED WITH THE STABILITY THIS CONSTRUCT PROVIDED. DOI: (B)(6) 2016. DOR: (B)(6) 2021. (LEFT HIP).

  Patient problems: Joint Laxity

  MAUDE report 12605056 ↗
• InjurySep 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT KEPT DISLOCATING. DOI: UNKNOWN. DOR: (B)(6) 2021. (UNKNOWN SIDE).

  Patient problems: Joint Dislocation

  MAUDE report 12433877 ↗
• InjuryFeb 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS INDICATED THAT PATIENT HAD AN ANTIBIOTIC SPACER PLACED ON 1/16/21. PATIENT FELL AND DISLOCATED HIS HIP. HE ALSO BROKE THE ACETAULAR CUP SPACER AWAY FROM HIS BONE DURING THIS FALL. A NEW ACETABULAR COMPONENT WAS CEMENTED IN PLACE AND THE NECK LENGTH WAS UPSIZED. PATIENT IS A NON COMPLIANT PATIENT PER DOCTOR. LOOSENING INTERFACE IS BONE TO CEMENT AND THE CEMENT MANUFACTURER IS UNKNOWN DOI: (B)(6) 2021, DOR: (B)(6) 2021.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 11359214 ↗
• InjurySep 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD REVISION DUE TO DISLOCATION. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10546845 ↗
• InjuryJan 23, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD 28MM BIOMET HEAD THAT LOOKED DISASSOCIATED FROM THE 40MM DEPUY BIPOLAR SHELL. DOI: (B)(6) 2019; DOR: (B)(6) 2020 (LEFT HIP).

  Patient problems: No Code Available

  MAUDE report 9621555 ↗
• InjuryJan 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT FELL OUT OF HIS TRACTOR, HE IS A FARMER, AND DISLOCATED HIS HIP. WHEN THE ER WAS TRYING TO REDUCE THE HIP THEY FOLDED THE LINER IN ON TOP OF ITSELF. WE THEN OPENED UP THE HIP AND REMOVED THE LINER AND SCREWS FROM THE CUP BECAUSE THEY WERE SITTING PROUD. SCREWS WERE IMPLANTED AT ORIGINAL SURGERY ON (B)(6) 2018. THEN IMPLANTED A NEW LINER AND 40 TS HEAD. LINER WAS STILL WELL FIXED EVEN AFTER IT WAS FOLDED ON TOP OF ITSELF. DOI: (B)(6) 2019; (B)(6) 2018 (SCREWS); DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9563756 ↗
• InjuryJan 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT RECEIVED IMPLANT UNKNOWN HIP SIDE ON (B)(6) 2019. REVISION ON (B)(6) 2019 BECAUSE OF PAIN AND LUXATION. THE PE RING WAS FOUND TO BE FRACTURED. FURTHER DETAILS UNKNOWN AT THE MOMENT.

  Patient problems: Anemia; Edema; Hematoma; Joint Dislocation; No Code Available; Pain; Seroma

  MAUDE report 9557504 ↗
• InjuryNov 26, 2019Fracture; Fracture

  SURGEON HAD A PATIENT WITH A 40 MM BIPOLAR HEAD AND 40 MM +4 10 DEGREE LINER IN SITU. HE HAD TO REMOVE THE SELF CENTERING BIPOLAR HEAD BECAUSE THE POLY INSERT IN THE HEAD¿S RIM THAT CLIPS INTO BIG METAL HEAD, BROKE. PATIENT STATUS/OUTCOME/CONSEQUENCES: YES.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9375692 ↗
• InjuryOct 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PFS AND MEDICAL RECORD RECEIVED. PFS ALLEGES SECOND REVISION DUE TO DISLOCATION RESULTING TO INFECTION, BLOOD CLOTS, SEVERE PAIN AND LIMITED MOBILITY. AFTER REVIEW OF MEDICAL RECORDS, IT WAS CONFIRMED THE PATIENT WAS RE-REVISED DUE TO INFECTION. OPERATIVE FINDING REPORTED APPEARED TO BE ISOLATED ABSCESS IN THE SUBFASCIAL AREA. OPERATIVE NOTE REPORTED PURULENT FLUID AND THE INFECTION DID NOT APPEAR TO TRACT DEEP IN THE HIP JOINT. DOI: (B)(6) 2015; DOR: (B)(6) 2016: LEFT HIP (2ND REVISION).

  Patient problems: Abscess; Joint Dislocation; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result; Thrombosis; Unspecified Infection

  MAUDE report 9213262 ↗
• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES COMPARTMENT SYNDROME AND WALKING DIFFICULTY. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED INFECTED LEFT TOTAL HIP ARTHROPLASTY. PROCEDURE NOTES INDICATED ALL GRAM STAINS AS WELL AS CELL COUNTS PER HIGH POWER FIELD WERE ACCEPTABLE LIMITS SHOWING NO EVIDENCE OF INFECTION. FURTHER DISSECTION WAS PERFORMED DOWN THE FEMUR SHOW EVIDENCE OF SIGNIFICANT BONE LOSS. AFTER THOROUGH INSPECTION THERE WAS A SIGNIFICANT MEDIAL BONY DEFICIT OF APPROXIMATELY 8 CM. ADDED HEIGHT OF PATIENT. DOI: (B)(6) 2011; DOR: (B)(6) 2011; LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Injury; No Code Available; Unspecified Infection

  MAUDE report 9187168 ↗
• InjuryOct 11, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP IN THE EARLY 2000¿S. UTILIZING A 40 MM BIPOLAR HEAD. THAT COMPONENT WAS REVISED TODAY FOR WEAR. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9179679 ↗
• InjuryJun 3, 2019Fracture; Device-Device Incompatibility; Device Dislodged or Dislocated; Fracture; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BIPOLAR HEAD, INNER PLASTIC HEAD LINERS IS "SCORED" WILL NOT ALLOW 28 HEAD TO SEAT INTO BIPOLAR HEAD. SURGICAL DELAY 10 MINUTES. DOE: (B)(6) 2019, UNKNOWN HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 8662526 ↗
• InjuryMar 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8404536 ↗
• InjuryJan 22, 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 8266444 ↗
• InjuryDec 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8161193 ↗