OMNI ARC Hip HC-21003-HARecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00841690115816), received between Feb 22, 2017 and Nov 7, 2021 — classified as 15 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY DATE IS (B)(6) 2013. THE REASON FOR REVISION IS REPORTED METALLOSIS. DURING THE REVISION, ALL ORIGINAL COMPONENTS WERE REMOVED AND REPLACED.

  Patient problems: Metal Related Pathology

  MAUDE report 12760624 ↗
• InjuryFeb 3, 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) 2013. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL STEM, MODULAR NECK AND FEMORAL HEAD WERE REMOVED. THE STEM WAS REPLACED WITH AN OMNI DISTRIBUTED STEM AND THE HEAD WAS REPLACED WITH A NON-OMNI COMPONENT.

  Patient problems: Pain

  MAUDE report 11277067 ↗
• InjuryMar 10, 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) 2014. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED PATIENT PAIN. DURING THE REVISION ALL OMNI PRODUCT WAS REMOVED AND REPLACED WITH NON-OMNI PRODUCT.

  Patient problems: Pain

  MAUDE report 9812451 ↗
• 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) 2012. THE REASON FOR REVISION IS REPORTED PATIENT PAIN AND ELEVATED METAL ION LEVELS. DURING THE REVISION, THE ORIGINAL OMNISTEM WAS REMOVED ALONG WITH THE ORIGINAL OMNI ACETABULAR INSERT. THE STEM WAS REPLACED WITH A NON-OMNI STEM AND THE INSERT WAS REVISED TO A NEW COMPONENT OF THE SAME SIZE.

  Patient problems: Pain

  MAUDE report 8795034 ↗
• InjuryMay 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2016. THE ORIGINAL SURGERY IS DATED (B)(6) 2013. THE REVISION WAS DONE MORE THAN 3 YEARS AFTER THE ORIGINAL SURGERY. THE REASON FOR REVISION IS REPORTED CORROSION IN THE DISCONNECTION JOINT AREA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8658469 ↗
• InjuryMay 13, 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) 2013. THE REVISION SURGERY OCCURED BECAUSE OF REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL OMNI COCR HEAD, FEMORAL STEM, AND MODULAR NECK WERE REMOVED AND REPLACED.

  Patient problems: Pain

  MAUDE report 8605490 ↗
• InjuryMar 25, 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) 2011. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED METALLOSIS. DURING THE REVISION, THE ORIGINAL OMNI SIZE 3 STEM, AND NECK WERE REMOVED.

  Patient problems: Reaction

  MAUDE report 8449852 ↗
• InjuryMar 8, 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) 2011. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED LOOSENING OF A NON-OMNI PRODUCT (CUP). DURING THE REVISION, THE OMNI ARC STEM, ARC NECK AND CERAMIC FEMORAL HEAD WERE REMOVED AND REPLACED WITH A PARAGON STEM AND NON-OMNI PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8403267 ↗
• InjuryFeb 1, 2019Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2014. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL STEM, NECK AND COCR HEAD WAS REMOVED AND REPLACED WITH A MONOBLOCK STEM AND CERAMIC FEMORAL HEAD.

  Patient problems: Pain

  MAUDE report 8297730 ↗
• InjuryFeb 1, 2019Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2012. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL STEM, NECK AND COCR HEAD WAS REMOVED AND REPLACED WITH A MONOBLOCK STEM AND CERAMIC FEMORAL HEAD.

  Patient problems: Pain

  MAUDE report 8297729 ↗
• InjuryFeb 1, 2019Appropriate 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) 2014. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL STEM, NECK AND COCR HEAD WAS REMOVED AND REPLACED WITH A MONOBLOCK STEM AND CERAMIC FEMORAL HEAD.

  Patient problems: Pain

  MAUDE report 8297726 ↗
• InjuryOct 19, 2018Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT HIP REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2013. THE REVISION SURGERY OCCURED BECAUSE OF REPORTED PATIENT PAIN. DURING THE REVISION, THE OMNI ARC STEM, MODULAR NECK AND CERAMIC FEMORAL HEAD WERE REMOVED AND REPLACED WITH NON-OMNI COMPONENTS.

  Patient problems: Pain

  MAUDE report 7986399 ↗
• 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) 2012. THE REVISION SURGERY OCCURRED BECAUSE OF METALLOSIS. DURING THE REVISION, THE ORIGINAL OMNI SIZE 3 HA AND POROUS COATED ARC STEM AND ARC NEUTRAL NECK WERE REMOVED AND REPLACED WITH A SIZE 5 X 14.6MM POROUS FEMORAL STEM, A 28 MM -3.5 COCR FEMORAL HEAD, AND A SIZE SHORT +47.5 MODULAR FEMORAL NECK WITH BOLT.

  Patient problems: Reaction

  MAUDE report 7545006 ↗
• InjuryNov 1, 2017Insufficient Device Problem Information

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2014. THE REVISION SURGERY OCCURRED BECAUSE OF PATIENT PAIN. DURING THIS REVISION, ALL THE ORIGINAL OMNI PRODUCT WAS REMOVED AND REPLACED WITH NON-OMNI PRODUCT. THE STEM, NECK AND HEAD WERE EXPLANTED AND EXCHANGED.

  Patient problems: Pain

  MAUDE report 6993894 ↗
• InjuryFeb 22, 2017Material Rupture

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2015. THE REVISION SURGERY OCCURRED BECAUSE OF A RUPTURED LIGAMENT. DURING THE REVISION, THE ORIGINAL ARC STEM, NECK, FEMORAL HEAD AND LINER WERE REVISED. THE SIZE 3 ARC FEMORAL STEM AND ANTEVERTED NECK WERE REVISED TO A K1 SIZE 7 FEMORAL STEM, THE 28MM X +3.5MM FEMORAL HEAD WAS REVISED TO A NEW HEAD OF THE SAME SIZE, AND THE ORIGINAL 59/28 LINER WAS REVISED TO A 55/28 LINER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6350371 ↗