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Double Mobility Liner 01.26.2848MHCRecalls & reported problems

Medacta International SA · HC PE Liner 28 / DMD · 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 in hip replacement surgery. The 48 reports mostly describe infections at the surgical site, pain, and hip joint dislocation or loosening, with several patients needing revision surgery to wash out the joint or replace the liner and femoral head. No deaths were reported. There are no recalls naming 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
48
Deaths reported
0
Injuries reported
48
Recalls naming it
0

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 07630030807244), received between Sep 26, 2017 and May 25, 2026 — classified as 48 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (9 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: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 2 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 2 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 3 reportsApr 2025: 1 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 2 reportsJan 2026: 1 reportsFeb 2026: 1 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available15
  • Adverse Event Without Identified Device or Use Problem13
  • Device Appears to Trigger Rejection9
  • Device Dislodged or Dislocated3
  • Contamination2
  • Inadequacy of Device Shape and/or Size1
  • Loose or Intermittent Connection1
  • Material Integrity Problem1

Patient problems

  • Unspecified Infection15
  • Medical device site infection8
  • Pain7
  • Unequal Limb Length4
  • Implant Pain3
  • Joint Dislocation3
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
  • Joint Disorder2

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 25, 2026Device Appears to Trigger Rejection

    AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 28MM BIOLOX HEAD S TO A SAME SIZE HEAD AND REVISED THE DOUBLE MOBILITY HC LINER D 28/DMD TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Medical device site infection

    MAUDE report 25268624 ↗
  • InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

    A REVISION SURGERY WAS PERFORMED ONE MONTH AFTER THE PRIMARY PROCEDURE DUE TO INFECTION OF UNKNOWN CAUSE. THE SURGEON PERFORMED A WASHOUT AND REPLACED THE LINER WITH THE SAME SIZE, AS WELL AS THE FEMORAL HEAD WITH THE SAME SIZE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Patient problems: Medical device site infection

    MAUDE report 24482262 ↗
  • InjuryFeb 12, 2026Device Appears to Trigger Rejection

    AT 6 YEARS 1 MONTH FROM PRIMARY,THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER WITH A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Medical device site infection

    MAUDE report 24321120 ↗
  • InjuryJan 14, 2026Device Appears to Trigger Rejection

    THE PATIENT HAD PRIMARY LEFT HIP SURGERY ON (B)(6) 2019. ON (B)(6) 2020, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURE. THE CAUSE OF THE FRACTURE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD TO A COMPETITOR STEM AND HEAD. THE SURGEON ALSO REVISED THE MEDACTA LINER TO A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT CAME IN FOR DUE TO A SUBSIDED COMPETITOR STEM. THE SURGEON REVISED THE MEDACTA LINER TO A MEDACTA LINER AND REVISED THE COMPETITOR HEAD AND STEM TO A DIFFERENT COMPETITOR HEAD AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2026, 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 A NEW COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER WITH A NEW MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Medical device site infection

    MAUDE report 24068441 ↗
  • InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT HAD REVISION SURGERY OF MEDACTA PRODUCT BUT THE PRIMARY TICKET FOR THE PATIENT CANNOT BE LOCATED. THE PATIENT CAME IN DUE TO INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON, ACCORDING TO THE COMPLAINT, REVISED A D 48 DM LINER AND 28MM M HEAD TO THE SAME SIZE MEDACTA LINER AND HEAD WITH A SLEEVE TO IMPROVE PATIENT STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Joint Laxity

    MAUDE report 23837347 ↗
  • InjuryDec 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    AT ABOUT 9 YEARS 1 MONTH 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 23837297 ↗
  • InjuryNov 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    ONE MONTH AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH AN INFECTION OF AN UNKNOWN PATHOGEN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Medical device site infection

    MAUDE report 23669502 ↗
  • InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AT ABOUT 12 YEARS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE WAS UNKNOWN. UPON REVISING, THE SURGEON OBSERVED AN ECCENTRICALLY WORN DM CONSTRUCT. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETE SUCCESSFULLY.

    Patient problems: Implant Pain

    MAUDE report 22058501 ↗
  • InjuryApr 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    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. THE PRIMARY SURGERY DATE IS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 21736861 ↗
  • InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT CAME IN REPORTING INSTABILITY. ABOUT 3 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE HEAD (WITH AN XXL HEAD) AND LINER (SAME REF) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Joint Laxity

    MAUDE report 21643546 ↗
  • InjuryMar 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    AT 5 YEARS 7 MONTHS 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: Medical device site infection

    MAUDE report 21585870 ↗
  • InjuryMar 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    THE PATIENT HAD AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 6 MONTHS FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Medical device site infection

    MAUDE report 21582149 ↗
  • InjuryDec 13, 2024Migration; Migration

    2 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN OF UNKNOWN CAUSE, CUP SHIFTING HAS BEEN HYPOTHESIZED. THE SURGEON REVISED THE CUP, LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Pain

    MAUDE report 20924286 ↗
  • InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT REPORTED INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. AT 24 DAYS FROM PRIMARY, THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Unequal Limb Length

    MAUDE report 20756050 ↗
  • InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. ABOUT 3 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Pain

    MAUDE report 20180525 ↗
  • InjurySep 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    THE PATIENT CAME IN REPORTING PAIN DUE TO IMPINGEMENT WITH THE DUAL MOBILITY LINER AND ILIOPSOAS, 8 YEAR AND 8 MONTHS AFTER THE PRIMARY. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON REPLACED THE HEAD WITH A +7 OPTION SLEEVE AND NEW DUAL MOBILITY LINER. HE WITNESSED A SIGNIFICANT AMOUNT OF SCAR TISSUE AROUND THE ACETABULUM.

    Patient problems: Joint Impingement; Pain

    MAUDE report 20143208 ↗
  • InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2013. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM WAS UNKNOWN. ON (B)(6) 2024 THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. AT ABOUT 1 MONTH AND A HALF FROM THE PRECEDENT SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A HEMATOMA. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER (PER STANDARD PROCEDURE). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Implant Pain

    MAUDE report 20037245 ↗
  • InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Unequal Limb Length

    MAUDE report 19266611 ↗
  • InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AT 1 YEAR AND 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO INSTABILITY AND LAXITY IN THE HIP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Implant Pain

    MAUDE report 19266607 ↗
  • InjuryApr 19, 2024Device 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: Unspecified Infection

    MAUDE report 19141712 ↗
  • InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY AT ABOUT 1 YEAR AFTER PRIMARY HIP SURGERY DUE TO A LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Unequal Limb Length

    MAUDE report 18254304 ↗
  • InjuryJul 20, 2023Unintended Movement; Unintended Movement

    REVISION SURGERY AT 4 YEARS AND 4 MONTHS POST PRIMARY FOR HIP INSTABILITY (SUB LUXATION). ALL DEVICES REVISED SUCCESSFULLY.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 17361803 ↗
  • InjuryJun 28, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    THE PATIENT CAME IN COMPLAINING OF A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 2 MONTHS POST PRIMARY, THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 17215240 ↗
  • InjuryMay 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

    AT ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME REPORTING PAIN DUE TO JOINT DISLOCATION. THE SURGEON REVISED SUCCESSFULLY THE DM HEAD AND LINER TO A NEW DM LINER WITH A LARGER HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Joint Dislocation

    MAUDE report 17001455 ↗
  • InjuryMar 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

    AFTER MEDACTA PRIMARY SURGERY PERFORMED ON (B)(6) 2022 (PREVIOUSLY THE PATIENT HAD COMPETITOR DEVICES), ON (B)(6) 2022 THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT DISLOCATION (DM LINER FROM THE DM CUP) AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER, HEAD, AND PROXIMAL BODY OF THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Pain

    MAUDE report 16467864 ↗

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

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Sources and updates

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