OMNI ARC Hip HC-21001-HARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00841690115779), received between Oct 17, 2017 and Mar 12, 2020 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 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 IS DATED (B)(6) 2014. THE REASON FOR REVISION IS UNKNOWN. DURING THE REVISION, THE ORIGINAL FEMORAL STEM, MODULAR NECK AND FEMORAL HEAD WERE REMOVED AND REPLACED WITH NON-OMNI COMPONENTS.

  Patient problems: No Code Available

  MAUDE report 9825895 ↗
• InjuryJan 31, 2020Insufficient 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) 2013. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL MODULAR NECK AND STEM WERE REMOVED AND REPLACED WITH A NEW MONOCLOCK FEMORAL STEM.

  Patient problems: Pain

  MAUDE report 9655161 ↗
• InjuryJan 13, 2020Insufficient 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) 2012. THE REASON FOR REVISION IS REPORTED PAIN. DURING THE REVISION, ALL OMNI COMPONENTS WERE REMOVED AND NON-OMNI PRODUCT WAS IMPLANTED.

  Patient problems: Pain

  MAUDE report 9582520 ↗
• InjuryJan 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY. REVISION SURGERY DATE UNKNOWN, THE ORIGINAL SURGERY IS DATED (B)(6) 2012. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, ALL COMPONENTS WERE REMOVED AND REPLACED WITH NON-OMNI PRODUCT.

  Patient problems: Pain

  MAUDE report 9548421 ↗
• InjurySep 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A SECOND HIP REVISION SURGERY ON (B)(6) 2016. THE FIRST REVISION SURGERY OCCURED ON (B)(6) 2014. THE ORIGINAL SURGERY WAS (B)(6) 2013. THE REASON FOR REVISION IS PATIENT PAIN. DURING THE REVISION, ALL ORIGINAL COMPONENTS WERE REMOVED AND REPLACED FOR NEW DEVICES.

  Patient problems: Pain

  MAUDE report 9085099 ↗
• InjuryAug 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT HIP REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2013. THE REASON FOR REVISION IS REPORTED PATIENT PAIN.

  Patient problems: Pain

  MAUDE report 8936228 ↗
• InjuryJul 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2012. THE REASON FOR REVISION IS REPORTED PSEUDOTUMOR.

  Patient problems: No Code Available

  MAUDE report 8828072 ↗
• InjuryMay 25, 2018Metal Shedding Debris

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2016. THE ORIGINAL SURGERY IS DATED (B)(6) 2011. THE REVISION SURGERY OCCURRED BECAUSE OF METALLOSIS. DURING THE REVISION, THE ORIGINAL OMNI SIZE 1 HA COATED ARC STEM, 8° ARC NECK, AND 36 MM +0 BIOLOX DELTA CERAMIC FEMORAL HEAD WERE REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCTS.

  Patient problems: Reaction

  MAUDE report 7545004 ↗
• InjuryJan 31, 2018Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2011. THE REVISION SURGERY OCCURRED BECAUSE OF OSTEOLYSIS. DURING THE REVISION, THE ORIGINAL OMNI SIZE 1 ARC STEM, ARC 8 DEGREE NECK, 32MM/10 DEGREE ACETABULAR INSERT, 48MM X 48MM DIAMETER ACETABULAR SHELL, AND SIZE 32MM FEMORAL HEAD WAS REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCT.

  Patient problems: Osteolysis

  MAUDE report 7231730 ↗
• InjuryOct 17, 2017Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2012. THE REVISION SURGERY OCCURRED BECAUSE OF PATIENT PAIN. DURING THE REVISION, THE ORIGINAL OMNI STEM AND INSERT WERE REMOVED. THE STEM WAS REPLACED WITH NON-OMNI PRODUCT, AND THE INSERT WAS REVISED TO A NEW OMNI IMPLANT.

  Patient problems: Pain

  MAUDE report 6955536 ↗