Trinity Acetabular Hip System with ECiMa Liners 322.04.636Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05055343869574), received between Dec 7, 2022 and Sep 30, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

1 other recall cover devices cleared under the same FDA submission (K111481); they may or may not involve this specific model.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Trinity / MetaFix Collared revision of the Cup, 2 Screws, ECiMa Liner, BIOLOX Delta Ceramic Head and Collared Stem after approximately 2 years and 7 months due to infection.Note: the Metafix Stem 579.2101 is not cleared in the USA.

  Patient problems: Unspecified Infection

  MAUDE report 50942691 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  TRINITY REVISION OF THE ECIMA LINER AND BIOLOX DELTA CERAMIC HEAD AFTER APPROXIMATELY 8 YEARS AND 10 MONTHS DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24739282 ↗
• InjuryMar 30, 2026Loss of Osseointegration; Osseointegration Problem

  TRINITY REVISION (OPS USED IN PRIMARY) OF THE ECIMA LINER AND BIOLOX DELTA CERAMIC HEAD AFTER APPROXIMATELY 4 MONTHS DUE TO LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24713170 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  TRINITY REVISION OF THE LINER AND HEAD AFTER APPROXIMATIVELY 2 WEEKS DUE TO INFECTION.NOTE 1: THIS REPORT IS UPDATED AS THE CUP REMAINED IN SITU. ONLY THE LINER AND THE HEAD WERE REVISED.NOTE 2: THIS IS A REGULARIZATION WITHIN THE FRAMEWORK OF A CLINICAL STUDY FOLLOWING A CHANGE IN OUR EVENT MONITORING PROCESS OF SAE FROM CLINICAL STUDY.

  Patient problems: Unspecified Infection

  MAUDE report 24680780 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  TRINITY/ METAFIX REVISION OF ECIMA LINER, BIOLOX DELTA CERAMIC HEAD AND STEM AFTER 2.5 WEEKS DUE TO INFECTION AND DISLOCATION.

  Patient problems: Unspecified Infection

  MAUDE report 24178507 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TRINITY REVISION OF THE ECIMA LINER AFTER APPROXIMATELY 3 YEARS AND 7 MONTHS DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 23826218 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TRINITY REVISION AFTER APPROXIMATIVELY 9 MONTHS DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23567194 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TRINITY REVISION OF THE ECIMA LINER AFTER APPROXIMATELY 3 WEEKS DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22274447 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TRINITY AND METAFIX REVISION - INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 15931374 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111481. One submission often covers many models, so check the product and lot details in each record.

• Z-2606-2021 · Jul 28, 2021 · Terminated
  Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and Corin Trinity Liner ECIMA, diameter 36mm Neutral 4mm EPW, Taper Size 4 (Elevate