OMNI Hip H3-53699Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00841690119302), received between Mar 18, 2019 and Jul 24, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2023Unstable; Unstable

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2023. THE ORIGINAL SURGERY IS DATED ON (B)(6) 2020. THE REASON FOR REVISION IS REPORTED DISLOCATION. DURING THE SURGERY, ORIGINAL FEMORAL HEAD WAS REVISED WITH A NEW NON-OMNI IMPLANT.

  Patient problems: Joint Dislocation

  MAUDE report 17386134 ↗
• InjuryJun 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2023. THE ORIGINAL SURGERY IS DATED (B)(6) 2021. THE REASON FOR REVISION IS REPORTED DISLOCATION. DURING THE SURGERY, ORIGINAL FEMORAL HEAD WAS REVISED WITH A NEW NON-OMNI IMPLANT.

  Patient problems: Joint Dislocation

  MAUDE report 17075995 ↗
• InjuryApr 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2023. THE ORIGINAL SURGERY DATE WAS (B)(6) 2021. THE REASON FOR REVISION IS INSTABILITY. DURING THE REVISION THE HEAD AND MODULAR NECK WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

  Patient problems: Joint Laxity

  MAUDE report 16773616 ↗
• InjuryOct 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY OCCURRED IN 07/06/2020. THE REVISION SURGERY OCCURRED BECAUSE OF POSSIBLE INFECTION. DURING THE REVISION, THE FEMORAL HEAD WAS REMOVED AND REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 10649981 ↗
• InjuryFeb 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY WAS (B)(6) 2012. THE REVISION SURGERY OCCURRED BECAUSE A NON-OMNI PRODUCT ACETABULAR (CUP) NEEDED A REVISION. DURING THE REVISION, THE OMNI NECK AND FEMORAL HEAD WERE REMOVED AND REPLACED. OMNI'S PRODUCT WAS NOT THE CAUSE OR REASON FOR THE REVISION. RISK ANALYSIS WAS NOT PERFORMED AS IT WAS A NON-OMNI PRODUCT.

  Patient problems: No Code Available

  MAUDE report 9763315 ↗
• InjuryNov 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2011. THE REASON FOR REVISION IS REPORTED DISLOCATION. DURING THE REVISION, THE ORIGINAL FEMORAL HEAD AND ACETABULAR INSERT WERE REMOVED AND REPLACED.

  Patient problems: Joint Dislocation; Joint Disorder

  MAUDE report 9386266 ↗
• InjuryMay 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2019. THE REASON FOR REVISION IS REPORTED DISLOCATION. DURING THE REVISION SURGERY, THE ORIGINAL FEMORAL CERAMIC HEAD WAS REPLACED WITH A COCR FEMORAL HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 8633549 ↗
• InjuryMar 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A SECOND HIP REVISION SURGERY ON 02/4/2019. THE FIRST REVISION IS DATED (B)(6) 2012. THE ORIGINAL SURGERY IS DATED (B)(6) 2011. THIS REVISION SURGERY OCCURRED BECAUSE OF REPORTED INSTABILITY AND DISLOCATION. DURING THE REVISION, THE 36MM X +0MM BIOLOX DELTA CERAMIC FEMORAL HEAD WAS REMOVED AND REPLACED WITH A 28MM + 3.5MM BIOLOX DELTA CERAMIC FEMORAL HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 8430125 ↗