OMNI Mod Hip 151456Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841690102786), received between Jun 20, 2018 and Oct 16, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2020Break; Break

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY IS DATED (B)(6) 2004. THE REASON FOR REVISION IS ANTI-ROTATION PIN BREAKAGE. DURING THE REVISION, THE ORIGINAL FEMORAL HEAD, MODULAR NECK AND MODULAR STEM WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Insufficient Information

  MAUDE report 10693660 ↗
• InjurySep 12, 2018Fracture

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2018. THE REVISION OCCURED BECAUSE OF A REPORTED PERI-PROSTHETIC FRACTURE. DURING THE REVISION THE ORIGINAL OMNI STEM, NECK AND FEMORAL HEAD WERE REMOVED FOR NON-OMNI COMPONENTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 7870662 ↗
• 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) 2018. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL OMNI SIZE 6 X 14.5MM APEX MOD STEM, SIZE +47.5 NEUTRAL MODULAR NECK, AND 36MM +4 BIOLOX DELTA CERAMIC FEMORAL HEAD WERE REMOVED AND REPLACED WITH A SIZE 7 X 16MM APEX MOD STEM, A SIZE +47.5 X 13° ANTEVERSION MODULAR NECK, AND A 36MM -4 BIOLOX DELTA CERAMIC FEMORAL HEAD.

  Patient problems: Unspecified Infection

  MAUDE report 7817814 ↗
• InjuryJun 20, 2018Naturally Worn

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2003. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED WEAR. DURING THE REVISION, THE ORIGINAL OMNI SIZE 6 X 14.5 MM FEMORAL STEM, MEDIUM 47.5 NECK, AND 28 MM +3.5 MM ALUMINA FEMORAL HEAD WERE REMOVED AND REPLACED WITH A SIZE 6 X 16 MM MODULAR STEM, MODULAR NECK 47.5 SHORT, AND SIZE 28 MMX+7 MM COCR FEMORAL HEAD.

  Patient problems: Failure of Implant

  MAUDE report 7618649 ↗