Delta Dual Mobility System 5885.09.040Recalls & reported problems
Limacorporate SPA · Liner #M for Mobile Liner Dia. 40 mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390086332), received between Feb 20, 2026 and Mar 6, 2026 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Implant Pain1
- Medical device site infection1
- Metal Related Pathology1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem
A HIP REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO DELAYED WOUND HEALING AND SUSPECTED INFECTION. THE SURGEON FOLLOWED THE STANDARD SURGICAL WORKFLOW TO GAIN ACCESS TO THE SITE, STARTING WITH DEBRIDEMENT OF THE TISSUE AROUND THE WOUND AND COLLECTING FLUID AND TISSUE SAMPLES ALONG THE WAY. THE DUAL-MOBILITY POLYETHYLENE HEAD, LINER AND DELTA TT CUP WERE ALL REMOVED AND REPLACED WITH NEW IMPLANTS. THE CUP WAS UPSIZED AND ADDITIONAL FIXATION SCREWS WERE IMPLANTED, WHILE THE CEMENTED STEM WAS LEFT IN SITU. A DRAIN WAS PLACED IN SITU AND A VACUUM DRESSING WAS APPLIED AFTER WOUND CLOSURE. THE EXPLANTED COMPONENTS INCLUDED: LINER #M FOR MOB. LINER Ø40 (PRODUCT CODE 5885.09.040, LOT 2516684, STER. N. (B)(4). DELTA-TT CUP - ACETABULAR CUP DIA.52 MM (LINER #MEDIUM) (PRODUCT CODE 5552.15.520, LOT 2422342, STER. N. (B)(4). MOBILE LINER ØINT 28 MM Ø40 MM (PRODUCT CODE 5566.50.401, LOT 25AT2ZC, STER. N. (B)(4) IT HAS BEEN REPORTED THAT THE PATIENT HAD MULTIPLE REVISION SURGERIES SINCE THE BEGINNING OF THE YEAR. PREVIOUS SURGERY WAS A REVISION DUE TO FRACTURE AND PERFORMED ON (B)(6) WHERE MOBILE LINER WAS IMPLANTED. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) WHERE THE LINER FOR MOBILE L
Patient problems: Medical device site infection
MAUDE report 24531026 ↗InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem
HIP REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO PAIN. THE PATIENT HAD INCREASING HIP PAIN AND MRI FINDINGS SHOWING A FLUID COLLECTION AROUND THE HIP. ASPIRATION OF THE FLUID SHOWED COBALT AND CHROMIUM (COCR) METAL IONS, WHICH LED THE SURGEON TO DECIDE TO REPLACE THE COCR DUAL MOBILITY BEARING. DURING SURGERY, AFTER EXPOSURE, THE MOBILE LINER AND FEMORAL HEAD WERE REMOVED. THE SURGEON THEN ATTEMPTED TO REMOVE THE COCR DUAL MOBILITY LINER BUT WAS NOT ABLE TO FREE IT AFTER APPROXIMATELY 10 MINUTES OF TRYING, DESPITE USING A PUNCH TO KNOCK THE RIM OF THE SHELL AND A SUCTION CUP EXTRACTION DEVICE. THE SURGEON DECIDED TO EXPLANT THE CUP WITH THE COCR DM LINER STILL IN SITU AND REPLACE IT WITH A REVISION CONSTRUCT FROM ANOTHER COMPANY. IN HIS REMARKS, THE SURGEON REPORTED THAT REMOVAL OF THE COCR DUAL MOBILITY LINER WAS VERY DIFFICULT AND THAT HE WOULD HAVE PREFERRED TO REMOVE IT AND REPLACE IT WITH AN XL PE LINER. HE ALSO INDICATED THAT DOES NOT ALLOW PHOTOS OF X RAYS OR BLOOD TEST RESULTS TO BE TAKEN, NOR DOES HE ALLOW EXPLANTED IMPLANTS TO BE RETRIEVED BY THE COMPANY. THE EXPLANTED COMPONENTS INCLUDED: LINER #M FOR MOB. LINER Ø40 (PRODUCT CODE 5885.09.040, LOT 2014876, STER. N
Patient problems: Implant Pain; Metal Related Pathology
MAUDE report 24401858 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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