Delta Dual Mobility System 5566.50.401Recalls & reported problems
Limacorporate SPA · Mobile Liner Dia. 40 mm for Head Dia. 28 mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390086325), received between Jan 7, 2025 and Jan 7, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Naturally Worn” (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.
Reports received per month
Most reported problems
Device problems
- Naturally Worn1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2025Naturally Worn; Naturally Worn
HIP REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO BONE FRACTURE. ACCORDING TO THE RECEIVED INFORMATION, THE SURGEON BELIEVES THE MOBILE LINER ØINT 28 MM Ø40 MM (PRODUCT CODE 5566.50.401, LOT #1406266 - STER. (B)(4)) HAD WORN CAUSING POLY DEBRIS TO ENTER THE PROXIMAL FEMUR LEADING TO WEAKLING OF THE BONE AND THEN TO FRACTURE. THE FOLLOWING COMPONENTS WERE REMOVED: · MOBILE LINER ØINT 28 MM Ø40 MM (PRODUCT CODE 5566.50.401, LOT #1406266 - STER. (B)(4)). · H-MAX S LATERALIZED FEMORAL STEM #15 (PRODUCT CODE 4251.20.150, LOT #1301117 - STER. (B)(4)). · FEMORAL MODULAR HEAD - S Ø28MM (PRODUCT CODE 5010.42.281, LOT #1481193 - STER. (B)(4)). THE ACETABULAR CUP AND NEUTRAL SPACER WERE RETAINED. IT WAS REPORTED THAT THE FEMORAL HEAD WAS STILL STUCK INSIDE THE EXPLANTED MOBILE LINER AFTER DEVICES REMOVAL. A COMPETITOR'S DUAL MOBILITY LINER IN POLY (40MM X 28MM) WAS IMPLANTED INTO THE SPACER. PATIENT IS A MALE, 76 YEARS OLD. NO OTHER CLINICAL INFORMATION WAS AVAILABLE. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2014. EVENT HAPPENED IN AUSTRALIA.
Patient problems: Bone Fracture(s)
MAUDE report 21091066 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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