OMNI Interface Acetabular System H5-44840Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841690119906), received between Dec 20, 2017 and Mar 11, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 16, 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.

• InjuryMar 11, 2021Appropriate 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 OCCURRED ON (B)(6) 2021. THE REVISION SURGERY OCCURRED BECAUSE OF POSSIBLE INFECTION. DURING THE REVISION, THE ORIGINAL ACETABULAR INSERT AND FEMORAL HEAD WERE REMOVED AND REPLACED BY NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 11468145 ↗
• InjurySep 11, 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 INFECTION. DURING THE REVISION, ALL ORIGINAL OMNI COMPONENTS WERE REMOVED AND REPLACED WITH NEW NON-OMNI DEVICES

  Patient problems: Unspecified Infection

  MAUDE report 8999604 ↗
• InjuryJul 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 OCCURED ON (B)(6) 2012. THE REVISION SURGERY OCCURED BECAUSE OF REPORTED PATIENT PAIN. DURING THE REVISION, THE ACETABULAR INSERT WAS REMOVED AND REPLACED WITH A NEW COMPONENT.

  Patient problems: Pain

  MAUDE report 8813656 ↗
• InjuryJul 16, 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 REVISION SURGERY OCCURED BECAUSE OF REPORTED DISLOCATION. DURING THE REVISION, THE ORIGINAL COCR FEMORAL HEAD, ACETABULAR INSERT AND SHELL WERE ALL REMOVED AND REPLACED WITH NEW PRODUCT.

  Patient problems: Joint Dislocation; Joint Disorder

  MAUDE report 8795035 ↗
• InjuryApr 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT HIP REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2018. THE REASON FOR REVISION WAS REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL ACETABULAR INSERT WAS REMOVED AND REPLACED WITH A NEW ACETABULAR INSERT.

  Patient problems: Pain

  MAUDE report 8503689 ↗
• InjuryOct 15, 2018Contamination

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT HIP REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2018. THE REVISION SURGERY OCCURED BECAUSE OF REPORTED PATIENT INFECTION. DURING THE REVISION, THE ACETABULAR INSERT AND FEMORAL COCR HEAD WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 7965389 ↗
• InjuryDec 20, 2017Contamination

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF INFECTION. DURING THIS REVISION, THE ORIGINAL OMNI IMPLANTS WERE REMOVED FOR TREATMENT OF WOUND.

  Patient problems: Unspecified Infection

  MAUDE report 7135372 ↗