OMNI ARC Hip HC-21002-HARecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00841690115793), received between May 25, 2018 and Sep 23, 2022 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2022Insufficient 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 DATE IS (B)(6) 2013. THE REASON FOR REVISION IS REPORTED METALLOSIS. DURING THE REVISION, THE STEM, NECK AND HEAD WERE REMOVED AND REPLACED WITH NON-OMNI IMPLANTS.

  Patient problems: Metal Related Pathology

  MAUDE report 15472741 ↗
• InjuryJul 7, 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. ALL COMPONENTS WERE REVISED TO NON-OMNI PRODUCT.

  Patient problems: Pain

  MAUDE report 12130723 ↗
• InjuryJun 18, 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) 2012. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL STEM, MODULAR NECK, LINER AND FEMORAL HEAD WERE REMOVED. THE STEM WAS REPLACED WITH CORIN STEM AND HEAD AND AN OMNI CUP AND INSERT.

  Patient problems: Pain

  MAUDE report 12027152 ↗
• InjuryJan 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A SECOND KNEE REVISION SURGERY ON (B)(6) 2020. THE FIRST REVISION SURGERY OCCURED ON (B)(6) 2016 AND THE ORIGINAL SURGERY OCCURED ON (B)(6) 2010. THE REASON FOR REVISION IS REPORTED PAIN. DURING THIS REVISION, THE ORIGINAL STEM WAS EXPLANTED AND REPLACED WITH NON-OMNI PRODUCT, AND THE NECK IMPLANTED DURING THE FIRST REVISION SURGERY WAS REMOVED AND REPLACED WITHIN-OMNI PRODUCT.

  Patient problems: Pain

  MAUDE report 9638773 ↗
• InjurySep 28, 2018Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT RIGHT HIP REVISION SURERY ON (B)(6) 2018. THE ORIGINAL SURGERY FOR THE RIGHT HIP IS DATED (B)(6) 2016, AND LEFT HIP ON (B)(6) 2017. THE REVISION SURGERY OCCURED BECAUSE OF ALLEGED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL STEM, NECK FEMORAL HEAD AND LINER WERE REMOVED AND REPLACED WITH A NEW MONOBLOCK STEM, FEMORAL HEAD AND ACETABULAR LINER.

  Patient problems: Pain

  MAUDE report 7920311 ↗
• InjurySep 24, 2018Device Slipped

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE REVISION, THE ORIGINAL OMNI STEM AND LINER WERE REMOVED. THE LINER WAS REPLACED WITH A NEW OMNI COMPONENT, WHILE THE STEM WAS REVISED USING A NON-OMNI PRODUCT.

  Patient problems: No Code Available

  MAUDE report 7902701 ↗
• InjurySep 6, 2018Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2010. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED PATIENT PAIN AND ELEVATED COBALT CHROMIUM LEVELS. DURING THE REVISION, THE ORIGINAL OMNI ARC STEM, NECK AND FEMERAL HEAD WERE REMOVED AND REPLACED WITH NON-OMNI PRODUCT.

  Patient problems: Pain

  MAUDE report 7852194 ↗
• InjuryAug 27, 2018Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A LEFT HIP REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2012. THE REVISION SURGERY OCCURED BECAUSE OF REPORTED PATIENT PAIN AND SORENESS. DURING THE REVISION, THE OMNI ARC SIZE 2 STEM, ARC NECK AND FEMORAL HEAD WERE REMOVED AND REPLACED WITH NON-OMNI PRODUCT.

  Patient problems: Pain

  MAUDE report 7819924 ↗
• InjuryAug 27, 2018Appropriate 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 OCCURED BECAUSE OF REPORTED PAIN AND POSSIBLE METALLOSIS. DURING THE REVISION, THE ORIGINAL OMNI ARC NECK AND SIZE 2 ARC STEM WERE REMOVED AND REPLACED WITH NON-OMNI COMPONENTS.

  Patient problems: Pain

  MAUDE report 7819923 ↗
• InjuryJun 6, 2018Material Fragmentation

  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 METALLOSIS, AS REPORTED. DURING THE REVISION, THE ORIGINAL OMNI SIZE 2 ARC STEM, ARC 12° NECK, AND 28MM +3.5 BIOLOX DELTA CERAMIC FEMORAL HEAD WAS REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCT.

  Patient problems: Failure of Implant

  MAUDE report 7575323 ↗
• 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) 2015. THE REVISION SURGERY OCCURRED BECAUSE OF METALLOSIS. DURING THE REVISION, THE ORIGINAL OMNI SIZE 2 HA COATED ARC STEM, ARC ANTEVERTED NECK, 28 MM +3.5 BIOLOX DELTA CERAMIC FEMORAL HEAD, AND SERF'S CI 53/28 E LINER WERE REMOVED AND REPLACED WITH A SIZE 4 LAT K1 POROUS FEMORAL STEM, 28 MM +0 BIOLOX DELTA FEMORAL HEAD, AND A SERF LINER OF THE SAME SIZE.

  Patient problems: Reaction

  MAUDE report 7545018 ↗
• InjuryMay 25, 2018Metal Shedding Debris

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2013. THE REVISION SURGERY OCCURRED BECAUSE OF METALLOSIS. DURING THE REVISION, THE ORIGINAL OMNI SIZE 28 MM FEMORAL HEAD WAS REMOVED AND REPLACED WITH A NEW COMPONENT OF THE SAME SIZE.

  Patient problems: Reaction

  MAUDE report 7545003 ↗