Double Mobility Liner 01.26.2246MHCRecalls & reported problems
Medacta International SA · HC PE Liner 22 / DMC · Class 2 · Implant
All models of Double Mobility Liner (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030806834), received between Jul 27, 2018 and Dec 27, 2024 — classified as 8 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available3
- Adverse Event Without Identified Device or Use Problem2
- Device Appears to Trigger Rejection2
- Microbial Contamination of Device1
Patient problems
- Unspecified Infection5
- Bone Fracture(s)1
- Joint Dislocation1
- Joint Laxity1
- Medical device site infection1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryDec 27, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
ALMOST ONE MONTH AFTER PRIMARY THE PATIENT DEVELOPED AN INFECTION. A WASHOUT WAS PERFORMED AND LINER AND HEAD WERE REVISIONED. SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 21026659 ↗InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HIP REVISION SURGERY AT ABOUT 9 YEARS AND 10 MONTHS. THE PATIENT REPORTED THAT THE JOINT WAS NOT STABLE WHEN RIDING A BIKE. DURING THE REVISION, A MICRO-FRACTURE WAS FOUND IN THE ACETABULUM WHEN THE CUP WAS REMOVED AND SIGNS OF WEAR ON THE POLY WERE DETECTED. NO INFECTION WAS DETECTED. THE SURGEON REVISED THE CUP, LINER, AND HEAD, TO ADD OFFSET AND A BIT OF LEG LENGTH TO INCREASE PATIENT'S STABILITY.
Patient problems: Bone Fracture(s); Joint Laxity
MAUDE report 19606526 ↗InjuryJun 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 17117954 ↗InjuryDec 7, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY FOR DISLOCATION OF THE DM POLY LINER FROM THE DM CONVERTER (DM POLY LINER AND COCR HEAD REMAINED COUPLED). THE SURGEON REVISED SUCCESSFULLY THE LINERS AND COCR HEAD.
Patient problems: Joint Dislocation
MAUDE report 10959367 ↗InjuryJul 5, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PERFORMED AFTER 1 YEAR AND 7 MONTHS FORM THE PRIMARY DUE TO AN INFECTION (THE TYPE OF THE PATHOGEN IS UNKNOWN). THE INLAY HAS BEEN REVISED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 8764331 ↗InjuryMay 27, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PERFORMED 1 YEAR AFTER PRIMARY DUE TO INFECTION. CUP AND LINER HAVE BEEN REMOVED, THE PATHOGEN IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 8644140 ↗InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem
1 MONTH AFTER PRIMARY REVISION SURGERY FOR INFECTION. THE SURGEON PERFORMED AN I&D, REVISED ANOTHER COMPANY'S HEAD WITH ANOTHER COMPANY'S HEAD AND REVISED THE LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 8548594 ↗InjuryJul 27, 2018Microbial Contamination of Device
ABOUT 1 MONTH AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A INFECTION CASE. LINER SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 7726664 ↗
Other Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 reports
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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