OMNI Hip H3-53604Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841690119289), received between Feb 6, 2019 and Jan 24, 2022 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY IS DATED ON (B)(6) 2020. THE REASON FOR REVISION IS REPORTED DISLOCATION. DURING THE SURGERY, ORIGINAL FEMORAL HEAD AND MODULAR NECK WITH BOLT WERE REPLACED FOR NEW COMPONENTS.

  Patient problems: Joint Dislocation

  MAUDE report 13335051 ↗
• InjuryOct 26, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6)2021. THE ORIGINAL SURGERY IS DATED (B)(6) 2021. THE REASON FOR REVISION IS REPORTED DISLOCATION. DURING THE SURGERY, ORIGINAL FEMORAL HEAD AND MODULAR NECK WERE REPLACED FOR NEW COMPONENTS.

  Patient problems: Joint Dislocation

  MAUDE report 12700238 ↗
• InjuryApr 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2018. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED DISLOCATION. DURING THE REVISION, THE ORIGINAL OMNI STEM, MODULAR NECK AND FEMORAL HEAD WERE REMOVED AND REPLACED.

  Patient problems: Joint Dislocation

  MAUDE report 8478816 ↗
• InjuryFeb 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2012. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED ASEPTIC LOOSENING. DURING THE REVISION, THE CERAMIC FEMORAL HEAD WAS REMOVED AND REPLACED WITH A NEW COMPONENT OF THE SAME SIZE.

  Patient problems: No Code Available

  MAUDE report 8313149 ↗