DURALOC 1241-10-527Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295018643), received between Dec 13, 2017 and Sep 10, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A PRIOR REVISION ON THE RIGHT HIP AT MEDICAL CENTER BY DR. ON (B)(6) 2025. PATIENT HAD DISLOCATED HER DURALOC CONSTRAINED LINER, SO SHE WAS BROUGHT BACK TODAY TO HAVE THE DURALOC CUP AND LINER REMOVED AND REPLACED WITH COMPETITIVE IMPLANTS. HEAD BALL WAS REMOVED AND REPLACED WITH A DEPUY LARGE TAPER, 28+11 HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 23022074 ↗
• InjuryOct 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT HEAD LINER EXCHANGED WAS PREFORMED UNEVENTFULLY. A SIGNIFICANT AMOUNT OF METALOSIS WAS EVIDENT LEADING SURGEON TO BELIEVE THE LOCKING RING HAD BEEN DISASSOCIATED FOR SOME TIME. NO PATIENT HARM OCCURRED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 17908064 ↗
• InjuryJan 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATED HIP. SURGEON DID NOT FEEL THE CUP POSITION WAS OPTIMAL. EXPLANTED THE CUP AND PUT IN A NEW CUP HEAD AND LINER. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16240342 ↗
• InjuryJul 22, 2022Naturally Worn; Naturally Worn

  PRIMARY IMPLANT OF DURALOC LINER AND LOCKING RING OCCURRED IN 2001. DURALOC POLY LINER AND LOCKING RING REVISED DUE TO POLY WEAR. COMPLAINT DATE WAS YESTERDAY. PATIENT WAS FEMALE. UNKNOWN AGE. SHE HAD A DURALOC 50/28 LINER AND 50MM LOCKING RING REVISED. ORIGINAL IMPLANT WAS 2001. NO LOT DETAILS AVAILABLE ORIGINAL LINER HAD BECOME THIN ON THE ARTICULATING SURFACE. SURGEON REVISED WITH NEW 50/28 LINER AND NEW 50MM LOCKING RING. DOI: (B)(6) 2021. DOR: (B)(6) 2022. UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 15085152 ↗
• InjuryAug 11, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A REVISED CUP DUE TO MULTIPLE DISLOCATIONS. A NEW CUP WAS PUT-IN A BETTER POSITION AND USED A NEW LINER AND A NEW HEAD. NO SURGICAL DELAY NOTED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10392245 ↗
• InjuryJul 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS USING THE TOILET AND WENT TO GET UP AND FELT HER HIP DISLOCATED. IN THE OR, IT WAS DISCOVERED THE LOCKING RING FOR THE CONSTRAINED LINER WAS NO LONGER ENGAGED IN THE POLY AND WAS SITTING ON THE FEMORAL NECK. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10276278 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT TO ADDRESS INFECTION. OPERATIVE NOTES REPORTED SEROUS FLUID DRAINING BUT NOT PURULENT. DOI: (B)(6) 2009; DOE: (B)(6) 2009; RIGHT HIP.

  Patient problems: Edema; No Code Available; Unspecified Infection

  MAUDE report 9729463 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS LEG LENGTH INEQUALITY AND CONTINUED PAIN. DOI: (B)(6) 2004; DOR: (B)(6) 2009; RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9729457 ↗
• InjuryMar 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS REPEATED DISLOCATION. REPLACED HEAD AND CONSTRAINED LINER. PATIENT HAD DEMENTIA AND ISN'T FOLLOWING POST OP PROTOCOL TO KEEP FROM DISLOCATING. DOI: UNKNOWN. DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8396058 ↗
• InjuryDec 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS CONTINUED DISLOCATION. PATIENT HAS SOME DEMENTIA AND CONTINUES TO NOT FOLLOW POST OP PROTOCOL.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8174687 ↗
• InjuryOct 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED FROM A FALL.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 7978276 ↗
• InjuryOct 12, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT CAME TO ER WITH A DISLOCATED HIP POST AND CONSTRAINED LINER.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 7960149 ↗
• InjurySep 13, 2018Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAS A RIGHT TOTAL HIP WITH AML STEM AND DURALOC CUP. THE PATIENT HAD A CONSTRAINED LINER IMPLANTED IN APRIL AND HAS DISLOCATED. THE RING TO THE LINER WAS OVER THE NECK OF THE STEM. THE SURGEON DECIDED TO REMOVE THE CUP AND IMPLANT ANOTHER WITH BETTER VERSION. THE STEM WAS RETAINED AND IS WELL FIXED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7872392 ↗
• InjuryJun 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. IT WAS ALSO INDICATED THAT THE IMPLANT DATE OF THE CUP IS UNKNOWN. CONSTRAINED LINER AND FEMORAL HEAD WERE IMPLANTED ON 4/4/18. DOI: (B)(6) 2018; DOR (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7600286 ↗
• InjuryMar 8, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS REPEATED DISLOCATION. DOI: UNKNOWN; DOR: (B)(6) 2018 RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7324280 ↗
• InjuryDec 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2017; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7114662 ↗