Delta Dual Mobility System 5885.09.042Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390020060), received between Jul 18, 2024 and Feb 25, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Mechanical Problem; Mechanical Problem

  DURING HIP SURGERY PERFORMED ON (B)(6) 2025, AN ISSUE WAS OBSERVED INTRAOPERATIVELY WITH THE LINER #L FOR MOBILE LINER Ø42 (PRODUCT CODE: 5885.09.042, BATCH N° 2430719, STERILIZATION N° 2400269) DESPITE BEING CORRECTLY POSITIONED, THE INSERT WAS MOBILIZING. ADDITIONALLY, THE COMPONENT, ALTHOUGH INITIALLY APPEARING STABLE, WOULD DISASSEMBLE FROM THE CUP WHEN MANEUVERS WERE PERFORMED. DUE TO THESE ISSUES, IT WAS NECESSARY TO USE ANOTHER POLYETHYLENE INSERT. PATIENT: MALE EVENT OCCURRED IN ITALY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459560 ↗
• InjuryJul 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  HIP REVISION SURGERY DUE TO LOOSENING OF THE LINER #L FOR MOBILE LINER Ø42 (PRODUCT CODE 5885.09.042, LOT 2115888, STER. (B)(4)) AND DELTA NEUTRAL SPACER #XL (PRODUCT CODE 5885.15.610, LOT 2014107, STER. (B)(4)). THE DEVICES WERE USED IN COMBINATION WITH THE FOLLOWING DEVICES: - DELTA MULTIHOLE TT CUP Ø74MM - LINER #XL - TI6AL4V - REF. (B)(4) - LOT 2005209, STER. (B)(4) - BONE SCREW Ø6,5 H.20MM - TI6AL4V - REF. (B)(4) - LOT 2200053, STER. (B)(4) - BONE SCREW Ø6,5 H.30MM - TI6AL4V - REF. (B)(4) - LOT 2126547, STER. (B)(4) - BONE SCREW Ø6,5 H.35MM - TI6AL4V - REF. (B)(4) - LOT 2124322, STER. (B)(4) - MOBILE LINER ØINT 28 MM Ø42 MM - UHMWPE - REF. (B)(4) - LOT 21AT08K, STER. (B)(4) - HEAD FROM ANOTHER MANUFACTURER - STEM FROM ANOTHER MANUFACTURER THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, THE PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. ACCORDING TO THE AVAILABLE INFORMATION PROVIDED BY THE COMPLAINT SOURCE, THE PATIENT HAD A POSITIVE EVOLUTION AND RECOVERY AFTER THE FIRST SURGERY, HE FOLLOWED POST-OPERATIVE RECOMMENDATION AND WAS LEADING A NORMAL LIFE. IT WAS ALSO REPORTED THAT THE PATIENT HAD ALWAYS HEARD "CLICKS" WHEN SITTING DOWN BUT WAS TOLD THIS WAS NORMAL. ON (B)(6) 2024

  Patient problems: Implant Pain

  MAUDE report 19772699 ↗