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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 2 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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

All Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate devices →

Sources and updates

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