NA 1014-72-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295001294), received between Mar 9, 2021 and Nov 8, 2023 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. NEW LINER CEMENTED IN AND HEAD IMPLANTED. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 18094628 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POLY WEAR CREATING A FEELING OF INSTABILITY. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 15826976 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE CUP BROKEN THROUGH THE MEDIAL WALL AND NEEDED REVISION DUE TO INSTABILITY AND PAIN. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE (NON-CEMENTED). NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11445138 ↗