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OMNI Interface Acetabular System H5-44436Recalls & reported problems

Omni Life Science, Inc. · ApeX-LNK Acetabular Insert, UHMWPE 0 degree Hood, D Insert/36mm ID · Class 2 · Implant

All models of OMNI Interface Acetabular System (22)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841690119869), received between Aug 27, 2018 and Jan 4, 2021 — classified as 5 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 16, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information2
  • Appropriate Device Problem Term/Code Not Available1
  • Microbial Contamination of Device1
  • Unstable1

Patient problems

  • Pain2
  • Failure of Implant1
  • No Information1
  • Unspecified Infection1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 4, 2021Appropriate Device Problem Term/Code Not Available

    A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY OCCURRED ON 05/01/2018. THE REASON FOR REVISION IS REPORTED PATIENT PAIN CAUSED BY A PSUEDOTUMOR. DURING THE REVISION, THE ACETABULAR INSERT WAS REMOVED AND EXCHANGED.

    Patient problems: Pain

    MAUDE report 11114709 ↗
  • InjuryMay 8, 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) 2016. THE REVISION SURGERY WAS DONE TO REPLACE A NON-OMNI STEM (THAT HAD BEEN IMPLANTED WITH AN OMNI SHELL AND LINER). DURING THE REVISION SURGERY, THE OMNI LINER WAS REMOVED AND REPLACED WITH A NEW OMNI COMPONENT.

    Patient problems: Failure of Implant

    MAUDE report 8591321 ↗
  • InjuryApr 3, 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) 2017. THE REASON FOR REVISION WAS REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL ACETABULAR INSERT WAS REMOVED AND REPLACED WITH A LARGER POLY LINER.

    Patient problems: Pain

    MAUDE report 8478817 ↗
  • InjuryDec 11, 2018Microbial Contamination of Device

    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 REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL OMNI ACETABULAR INSERT AND FEMORAL HEAD WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

    Patient problems: Unspecified Infection

    MAUDE report 8150177 ↗
  • InjuryAug 27, 2018Unstable

    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 INSTABILITY. DURING THE REVISION, THE ORIGINAL OMNI 36MM ID X 0 DEGREE HOOD ACETABULAR INSERT WAS REMOVED AND REPLACED WITH A 36MM ID X 10° HOOD ACETABULAR INSERT.

    Patient problems: No Information

    MAUDE report 7817828 ↗

Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices

All Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices →

Sources and updates

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