NA 1018-12-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295001331), received between Feb 1, 2018 and Jan 2, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEAD EXCHANGE WITH COMPETITIVE COMPANY¿S LINER EXCHANGE DUE TO INSTABILITY. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23945488 ↗
• 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 23022077 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRIMARY HIP SURGERY WAS DONE APPROXIMATELY 30 YEARS AGO, POLY WEAR TO LINER. CUP AND HEAD WERE REMOVED. COMPETITOR CAGE AND CUP WERE IMPLANTED. BONE DEGRADATION AND INSTABILITY WAS REPORTED DUE TO POLY WEAR. DOI: 30 YEARS AGO; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 15501129 ↗
• InjurySep 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE REVISION IS DUE TO A DISLOCATING HIP. DOI: (B)(6) 1999, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12489134 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS A PAINFUL HIP. REVISED & REMOVED A ZIMMER CUP, LINER, AND HEAD. DEPUY STEM WAS RETAINED IN THE PATIENT. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 10195240 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SUPERIOR ECCENTRIC EROSION OF THE LINER. PAIN WAS ALSO REPORTED.

  Patient problems: No Code Available; Pain

  MAUDE report 8550360 ↗
• InjuryFeb 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Pain

  MAUDE report 7233875 ↗