OMNI ARC Hip HC-21004-HARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841690115830), received between Nov 1, 2018 and Oct 22, 2021 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 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.

  Patient problems: Pain

  MAUDE report 12682323 ↗
• InjuryOct 21, 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) 2014. 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.

  Patient problems: Pain

  MAUDE report 12677027 ↗
• InjuryMay 8, 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 OCCURRED ON (B)(6) 2014. THE REASON FOR REVISION IS REPORTED PAIN. DURING THIS REVISION, DR. REMOVED THE ARC STEM, NECK AND HEAD ALL OMNI. HE LEFT THE ZIMMER CUP AND REPLACED THE LINER. HE REPLACED THE ARC STEM WITH A PARAGON STEM AND CERAMIC OMNI HEAD.

  Patient problems: Pain

  MAUDE report 10038861 ↗
• InjuryJun 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) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2013. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL FEMORAL STEM, MODULAR NECK AND COCR HEAD WERE REMOVED AND REPLACED.

  Patient problems: Pain

  MAUDE report 8696281 ↗
• 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 8297727 ↗
• InjuryNov 1, 2018Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED INVOLVING A PATIENT WHO UNDERWENT HIP REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REASON FOR REVISION IS REPORTED PATIENT PIN. DURING THE REVISION, THE MODULAR STEM AND NECK WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Pain

  MAUDE report 8028664 ↗