Double Mobility Liner 01.26.2858MHCRecalls & reported problems
Medacta International SA · HC PE Liner 28 / DMI · Class 2 · Implant
All models of Double Mobility Liner (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07630030807442), received between Aug 30, 2017 and Jun 26, 2026 — classified as 15 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 Available4
- Device Dislodged or Dislocated4
- Adverse Event Without Identified Device or Use Problem3
- Device Appears to Trigger Rejection1
- Device Operates Differently Than Expected1
- Fracture1
- Insufficient Device Problem Information1
- Microbial Contamination of Device1
Patient problems
- Unspecified Infection7
- Joint Dislocation4
- Medical device site infection2
- Bone Fracture(s)1
- Hematoma1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2026Device Appears to Trigger Rejection
AT ABOUT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REVISED THE 28MM BIOLOX HEAD S TO A SAME SIZE HEAD AND REVISED THE D 28/DMI HC LINER TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25632994 ↗InjuryDec 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2023, THE PATIENT HAD PRIMARY RIGHT HIP SURGERY. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE THAT WAS CAUSED FROM FALLING. THE SURGEON CABLED THE FRACTURE, REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2025, THE PATIENT CAME IN DUE TO PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE COMPETITOR STEM AND HEAD WITH A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE CASE WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO PAIN ASSOCIATED WITH A DISLOCATION. THE SURGEON SWAPPED THE DM LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO PAIN ASSOCIATED WITH A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON SWAPPED THE LINER WITH COMPETITOR`S LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 23836920 ↗InjuryDec 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2023, THE PATIENT UNDERWENT PRIMARY SURGERY. ON (B)(6) 2023, THE PATIENT RETURNED REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE SUSTAINED AFTER A FALL. THE SURGEON CABLED THE FRACTURE, REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS, AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT PRESENTED WITH PAIN OF UNKNOWN CAUSE. THE SURGEON REVISED THE COMPETITOR STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE CASE WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT RETURNED WITH PAIN ASSOCIATED WITH A DISLOCATION OF THE DM LINER FROM THE DM CUP. THE SURGEON REPLACED THE DM LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 23725622 ↗InjuryMay 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
AT ABOUT 20 DAYS AFTER THE PRIMARY SURGERY, REVISION SURGERY PERFORMED DUE TO DISSOCIATION OF THE INOX HEAD FROM THE LINER DM. ORIGINALLY THE JOINT DISLOCATED AND IT APPEARS THAT DURING THE CLOSE REDUCTION THE HEAD DISSOCIATED FROM THE LINER DM. THE SURGEON REVISED SUCCESSFULLY THE HEAD AND LINER (SAME SIZE).
Patient problems: Joint Dislocation
MAUDE report 19237993 ↗InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AT ABOUT 1 MONTH AND HALF AFTER 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: Medical device site infection
MAUDE report 17842212 ↗InjuryFeb 1, 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 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 13415525 ↗InjuryOct 8, 2020Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN, 2 MONTHS AFTER PRIMARY SURGERY, 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 10647876 ↗InjuryApr 21, 2020Fracture; Appropriate Device Problem Term/Code Not Available
ONE MONTH AFTER PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE. THE SURGEON CABLED THE FRACTURE, REVISED THE COMPETITOR'S STEM AND HEAD, AND REVISED THE MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REASON OF THE FRACTURE IS UNKNOWN.
Patient problems: Bone Fracture(s)
MAUDE report 9980340 ↗InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY NEEDED AFTER 9 MONTHS FROM THE PRIMARY DUE TO SIGNS OF AN INFECTION. 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 9755009 ↗InjuryFeb 21, 2020Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 1 MONTH AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE CERAMIC HEAD AND POLY LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 9738054 ↗InjuryFeb 6, 2020Device Dislodged or Dislocated
THE PATIENT HAD A PRIMARY HIP SURGERY AND WAS IMPLANTED WITH COMPETITOR ITEMS. THE DATE OF THE PRIMARY SURGERY IS UNKNOWN. SUBSEQUENTLY ON (B)(6) 2019, THE PATIENT CAME IN DUE TO METALLOSIS IN THE HIP. THE SURGEON REVISED THE PATIENT WITH A MEDACTA LINER. PRESENTLY, ON (B)(6) 2020, ABOUT 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE COMPETITOR HEAD AND MEDACTA LINER.
Patient problems: Joint Dislocation
MAUDE report 9675221 ↗InjuryDec 6, 2018Microbial Contamination of Device
I&D AND LINER REVISION PERFORMED 34 DAYS AFTER PRIMARY SURGERY DUE TO SIGNS OF INFECTION, THE PATHOGEN IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 8137076 ↗InjuryDec 6, 2017Device Operates Differently Than Expected
THE PATIENT CAME IN PRESENTING WITH A HEMATOMA. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Hematoma
MAUDE report 7087191 ↗InjuryOct 13, 2017Adverse Event Without Identified Device or Use Problem
THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON WASHED OUT THE HIP AND LEFT ALL IMPLANTS IN PLACE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATHOGEN IS NOT AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 6947206 ↗InjuryAug 30, 2017Insufficient Device Problem Information
THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS CONFIRMED AS STAPHYLOCCOCUS. THE SURGEON SWAPPED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 6829710 ↗
Other Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate devices
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- 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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