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Double Mobility Liner 01.26.2850MHCRecalls & reported problems

Medacta International SA · HC PE Liner 28 / DME · 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 hip liner is the plastic insert used in hip replacement surgery. Its reports mostly describe the liner slipping out of place or becoming unstable, along with infection and pain that led patients to have revision surgery; a few mention the body rejecting the implant or material breaking. There are 54 reports, no deaths and 54 injuries. 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
54
Deaths reported
0
Injuries reported
54
Recalls naming it
0

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 07630030807282), received between Jul 28, 2017 and Jun 30, 2026 — classified as 54 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (13 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: 2 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 1 reportsApr 2025: 2 reportsMay 2025: 1 reportsJun 2025: 1 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 3 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 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 Available20
  • Device Appears to Trigger Rejection13
  • Adverse Event Without Identified Device or Use Problem8
  • Device Dislodged or Dislocated7
  • Break1
  • Device Issue1
  • Insufficient Device Problem Information1
  • Loose or Intermittent Connection1

Patient problems

  • Unspecified Infection25
  • Joint Dislocation7
  • Pain7
  • Medical device site infection6
  • Implant Pain3
  • Joint Laxity3
  • Bacterial Infection2
  • Joint Disorder2

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 30, 2026Device Dislodged or Dislocated

    THE PATIENT HAD PAIN DUE TO A DISLOCATION OF THE DM LINER FROM THE DM CONVERTER LINER. THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE 28 MM BIOLOX DELTA HEAD L TO A COCR BALL HEAD 12/14 D 28 MM SIZE XL AND REVISED THE DOUBLE MOBILITY HC LINER D 28/DME TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD AN MPACT MH WITH DM CONVERTER ON (B)(6) 2026 IN A REVISION OF COMPETITOR DEVICES.

    Patient problems: Joint Dislocation

    MAUDE report 25663304 ↗
  • InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

    AT 1 YEAR 11 MONTHS FROM PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE D 28 DOUBLE MOBILITY LINER TO A LINER OF THE SAME SIZE AND REVISED THE 28MM BIOLOX HEAD TO A HEAD OF THE SAME SIZE WITH A BIOLOX OPTION SLEEVE L. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Implant Pain; Joint Laxity

    MAUDE report 24588556 ↗
  • InjuryDec 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    AT ABOUT 2 MONTHS 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 HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Medical device site infection

    MAUDE report 23837351 ↗
  • InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT HAD PRIMARY LEFT HIP SURGERY ON (B)(6) 2011. ON (B)(6) 2016, THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON NOTICED THE STEM WAS LOOSE. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGEON IMPLANTED ANOTHER COMPETITOR STEM AND HEAD WITH A MEDACTA LINER ((B)(4)). PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO HIP PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE COMPETITOR STEM AND HEAD TO ANOTHER COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA DM LINER TO A MEDATA DM LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Implant Pain

    MAUDE report 23836933 ↗
  • InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY FROM 1 YEAR AND 7 MONTHS POST PRIMARY DUE TO HIP INSTABILITY. THE SURGEON REVISED THE LINER AND REPLACED THE HEAD WITH AN OPTION HEAD/SLEEVE TO PROVIDE GREATER STABILITY FOR THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Joint Laxity

    MAUDE report 23690769 ↗
  • InjuryNov 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND SWAPPED THE LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Medical device site infection

    MAUDE report 23477174 ↗
  • InjuryJul 18, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

    AT ABOUT 4 YEARS 11 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE CUP. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE LINER TO SEMI-COSTRAINED, THE HEAD TO ANOTHER MEDACTA HEAD AND THE CUP TO A COMPETITOR'S. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Implant Pain

    MAUDE report 22539991 ↗
  • InjuryJun 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON THE MEDACTA STEM TO A COMPETITOR STEM AND REVISED THE MEDACTA HEAD AND LINER TO DM. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN REPROTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE CUP. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Joint Dislocation; Pain

    MAUDE report 22158056 ↗
  • InjuryMay 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    AT ABOUT 2 MONTHS 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 22002799 ↗
  • InjuryApr 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    AT ABOUT 2 MONTHS 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 21933167 ↗
  • InjuryApr 29, 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. ABOUT 10 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Medical device site infection

    MAUDE report 21926122 ↗
  • InjuryMar 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    AT ABOUT 1 MONTH 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 21718750 ↗
  • InjuryFeb 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    AT ABOUT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY

    Patient problems: Medical device site infection

    MAUDE report 21292462 ↗
  • InjurySep 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING AND 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. ON (B)(6) 2024 (THREE MONTHS AFTER LAST REVISION), THE HAD PAIN DUE TO A DISLOCATION OF THE LINER FROM THE DM CONVERTER LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE COCR DIDN'T DISLOCATE FROM THE DM LINER. THE DM CONVERTER DIDN'T DISLOCATE FROM THE SHELL.

    Patient problems: Joint Dislocation

    MAUDE report 20237350 ↗
  • InjuryApr 24, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    HIP REVISION SURGERY FOR INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 2 MONTHS AND A HALF POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Unspecified Infection

    MAUDE report 19173495 ↗
  • InjuryApr 19, 2024Device 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 WEEK 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 19141713 ↗
  • InjurySep 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    HOLD PS 9/20. THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMUR THAT WAS CAUSED FROM FALLING AND TWISTING THE LEG. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMUR THAT WAS CAUSED FROM FALLING. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD WITH COMPETITOR PRODUCTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, 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 17779918 ↗
  • InjurySep 11, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    AT 2 YEARS AND 1 MONTH FROM THE PRIMARY, REVISION DUE TO REDUCED LEG LENGTH AND RELATED LUXATION RISK. INLAY CHANGE AND ELONGATION WITH COMPETITOR'S HEAD.

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

    MAUDE report 17718219 ↗
  • InjurySep 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. SOON AFTER THE PRIMARY HIP SURGERY, THE PATIENT SUSTAINED A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED ALL IMPLANTS SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT LUXATION (DISLOCATION OF THE HEAD AND LINER FROM THE CUP) AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER SUCCESSFULLY.

    Patient problems: Pain

    MAUDE report 17690081 ↗
  • InjuryAug 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

    ON THE SAME DAY OF THE PRIMARY, THE PATIENT SUSTAINED A JOINT DISLOCATION. THE SURGEON PERFORMED SURGERY ON THE PATIENT AGAIN AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Joint Dislocation

    MAUDE report 17649308 ↗
  • InjuryJul 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    AT ABOUT 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 HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Unspecified Infection

    MAUDE report 17396947 ↗
  • InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AT ABOUT 12 YEARS 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON SUSPECTED ILIOPSOAS TENDON IMPINGEMENT WITH THE DM LINER. THE SURGEON REVISED THE HEAD (UPSIZED TO ADD OFFSET) AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Pain

    MAUDE report 16868192 ↗
  • InjuryFeb 8, 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 16322497 ↗
  • InjuryDec 13, 2022Break; Break

    THE PATIENT HAS A PRIMARY HIP SURGERY ON (B)(6) 2010. THE SURGEON USED ANOTHER COMPANY'S HEAD AND STEM WITH MEDACTA CUP AND LINER. THE PATIENT WAS REVISED ON (B)(6) 2016. THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON NOTICED THE STEM HAD SUBSIDED. THE SURGEON REVISED THE OTHER COMPANY'S PRODUCT ALONG WITH THE MEDACTA POLY. THE CUP REMAINED IN PLACE. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT HAD A SPINAL FUSION SURGERY AND SOON AFTER STARTING FEELING PAIN IN THE HIP. WHEN THE SURGEON EVALUATED THE PATIENT, IT WAS NOTED THAT THE HIP BECAME UNSTABLE AFTER THE SPINAL FUSION SURGERY. THE SURGEON REVISED THE CUP, HEAD, AND LINER WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE LINER WAS FOUND BROKEN.

    Patient problems: Pain

    MAUDE report 15969322 ↗
  • InjurySep 1, 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 15333461 ↗

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

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Sources and updates

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