Double Mobility Liner 01.26.2856MHCRecalls & reported problems
Medacta International SA · HC PE Liner 28 / DMH · Class 2 · Implant
All models of Double Mobility Liner (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medacta Double Mobility Liner is the plastic insert used inside a hip replacement cup. The 31 reports mostly describe infections of unknown origin appearing weeks to months after surgery, along with hip dislocation and a worn liner after many years, often needing revision surgery. There are 31 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 07630030807411), received between Jan 19, 2018 and Nov 5, 2025 — classified as 31 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (8 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 Available13
- Device Appears to Trigger Rejection8
- Device Dislodged or Dislocated4
- Adverse Event Without Identified Device or Use Problem3
- Naturally Worn2
- Inadequacy of Device Shape and/or Size1
- Insufficient Device Problem Information1
Patient problems
- Unspecified Infection16
- Medical device site infection6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Implant Pain2
- Joint Dislocation2
- Unequal Limb Length2
- Pain1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
InjuryNov 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
16 DAYS AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH AN INFECTION OF UNKNOWN ORIGIN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 23477172 ↗InjuryJun 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 22175057 ↗InjuryApr 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT 2 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 21917678 ↗InjuryMar 26, 2025Naturally Worn; Naturally Worn
AT ABOUT 10 YEARS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A WORN LINER. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 21695299 ↗InjuryFeb 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
DURING POST-OP RECOVERY AFTER THE PRIMARY HIP SURGERY (THE SAME DAY OF PRIMARY SURGERY), THE PATIENT HIP LUXATED, THE LINER FROM THE CUP. THE SURGEON REVISED THE PATIENT'S HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21432762 ↗InjuryFeb 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 3 WEEKS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 21418879 ↗InjuryNov 14, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 4 MONTHS POST PRIMARY REVISION DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 20683974 ↗InjurySep 25, 2024Naturally Worn; Naturally Worn
REVISION SURGERY AT ABOUT 10 YEARS 5 MONTHS, LINER AND HEAD REVISED. IT IS SUSPECTED PE HC LINER WEAR.
Patient problems: Pain
MAUDE report 20298886 ↗InjuryJan 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO A TUMOR. ON (B)(6) 2022, THE SURGEON REVISED THE HEAD AND LINER. PRESENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO LINER WEAR. THE SURGEON REVISED THE LINER, HEAD AND OPTION SLEEVE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18482453 ↗InjuryJan 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN REPORTING AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. AT ABOUT 4 MONTHS FROM PRIMARY THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unequal Limb Length
MAUDE report 18482447 ↗InjuryJun 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 5 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 17161592 ↗InjuryMay 31, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
AT ABOUT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 17029895 ↗InjuryJan 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE PATIENT CAME IN DUE TO SIGNS OF A STAPHYLOCOCCUS INFECTION AND THE CAUSE IS UNKNOWN. AT ABOUT 2 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED ALL IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 16156630 ↗InjuryOct 3, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 15527286 ↗InjuryMay 24, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER 20 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 14484948 ↗InjuryDec 3, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN 3 MONTHS AFTER THE PRIMARY SURGERY REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A MEDACTA STEM AND HEAD AND REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 12923715 ↗InjuryNov 25, 2021Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AFTER ABOUT 1 MONTH AND A HALF FROM THE PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 12873495 ↗InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem
2 MONTHS AFTER THE PRIMARY SURGERY THE SURGEON REMOVED THE IMPLANTS DUE TO INFECTION. THE CUP, LINER AND HEAD WERE MEDACTA WHILE THE STEM WAS A COMPETITOR PRODUCT. THE BALL HEAD LOT IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 12405771 ↗InjuryJul 21, 2021Inadequacy of Device Shape and/or Size
THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURE THAT WAS CAUSE FROM FALLING. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A LEG LENGTH DISCREPANCY. THE CAUSE OF THE LEG LENGTH DISCREPANCY IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unequal Limb Length
MAUDE report 12202535 ↗InjuryNov 30, 2020Appropriate Device Problem Term/Code Not Available
TWO MONTHS AFTER PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE COMPETITOR STEM AND HEAD WITH COMPETITOR PRODUCTS, AND REVISED THE VERSAFITCUP DM LINER HC 56/28 WITH A VERSAFITCUP DM LINER HC 56/28. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 10919853 ↗InjuryJun 17, 2020Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. 4 MOTHS AFTER PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, OPTION SLEEVE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE AGENT STATED THAT ANOTHER COMPANY'S STEM AND CUP WERE ALSO EXPLANTED AND THAT AN ANTIBIOTIC SPACER WAS IMPLANTED. NO NEW MEDACTA COMPONENTS WERE IMPLANTED DURING THIS REVISION.
Patient problems: Unspecified Infection
MAUDE report 10161719 ↗InjuryMar 24, 2020Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN, 6 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 9870915 ↗InjuryJan 13, 2020Appropriate Device Problem Term/Code Not Available
ABOUT 1 MONTH AFTER PRIMARY REVISION SURGERY FOR INFECTION. HEAD AND LINER REVISED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 9580030 ↗InjuryNov 7, 2019Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN, 1 MONTH AFTER PRIMARY SURGERY, COMPLAINING OF PAIN DUE TO LACK OF HEALING ON THE WOUND SITE. THE SURGEON PERFORMED A WASHOUT AND REVISED THE MEDACTA 28MM COCR HEAD M WITH A MEDACTA 28MM COCR HEAD M AND THE MEDACTA VERSAFITCUP DM LINER HC 56/28 WITH A MEDACTA VERSAFITCUP DM LINER HC 56/28 DUE TO SUSPECT OF INFECTION. NO DEEP INFECTION CONFIRMED DURING AND AFTER SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 9289628 ↗InjuryJul 11, 2019Appropriate Device Problem Term/Code Not Available
ON (B)(6) WE WERE INFORMED ABOUT A REVISION SURGERY PERFORMED ON (B)(6), AFTER 1 YEAR FROM THE PRIMARY DUE TO AND INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 8780239 ↗
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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