OMNI Hip H3-53600Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841690119272), received between Jul 6, 2018 and Jul 9, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2024. THE ORIGINAL SURGERY DATE WAS (B)(6) 2022. THE REASON FOR REVISION IS INSTABILITY. DURING THE REVISION THE OMNI HEAD AND MODULAR NECK AS WELL AS TRINITY INSERT AND LINER, WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

  Patient problems: Joint Laxity

  MAUDE report 19700214 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2023. THE ORIGINAL SURGERY IS DATED (B)(6) 2022. THE REASON FOR REVISION IS REPORTED DISLOCATION. DURING THE SURGERY, ORIGINAL FEMORAL HEAD AND NECK WAS REVISED WITH A NEW OMNI HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 17553924 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2023. THE ORIGINAL SURGERY IS DATED (B)(6) 2012. THE REASON FOR REVISION IS REPORTED DISLOCATION. DURING THE SURGERY, ORIGINAL FEMORAL HEAD WAS REVISED WITH A NEW OMNI HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 17495177 ↗
• InjuryApr 12, 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) 2018. 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 16729187 ↗
• InjuryMay 26, 2022Device Dislodged or Dislocated

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2022. THE ORIGINAL SURGERY IS DATED (B)(6) 2021. THE REASON FOR REVISION IS REPORTED DISLOCATION. DURING THE SURGERY, ORIGINAL FEMORAL HEAD WAS REPLACED FOR NEW COMPONENT.

  Patient problems: Joint Dislocation

  MAUDE report 14515569 ↗
• InjurySep 16, 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 12485740 ↗
• InjuryNov 21, 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, THE FEMORAL HEAD AND MODULAR NECK WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Joint Dislocation; Joint Disorder

  MAUDE report 9356541 ↗
• InjuryNov 12, 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) 2018. THE REASON FOR REVISION IS REPORTED PATIENT DISLOCATION. DURING THE REVISION, THE FEMORAL HEAD WAS REMOVED AND REPLACED WITH A NEW COMPONENT.

  Patient problems: Joint Dislocation

  MAUDE report 9312456 ↗
• InjuryJul 6, 2018Mechanical Problem

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2015. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED DISLOCATION. DURING THE REVISION, THE ORIGINAL OMNI 36 MM +0 BIOLOX DELTA CERAMIC FEMORAL HEAD WAS REMOVED AND REPLACED WITH 36 MM +8 BIOLOX DELTA CERAMIC FEMORAL HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 7667447 ↗