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Double Mobility Liner 01.26.2860MHCRecalls & reported problems

Medacta International SA · HC PE Liner 28 / DML · Class 2 · Implant

All models of Double Mobility Liner (20)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030807473), received between Feb 23, 2018 and Jul 19, 2023 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Dent in Material” (1 report).

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.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available4
  • Dent in Material1
  • Device Appears to Trigger Rejection1
  • Device Dislodged or Dislocated1

Patient problems

  • Unspecified Infection3
  • Discharge1
  • Erythema1
  • Hematoma1
  • No Code Available1
  • No Known Impact Or Consequence To Patient1
  • Pain1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 19, 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 2 YEARS AND 11 MONTHS AFTER THE PRIMARY DATE, THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Unspecified Infection

    MAUDE report 17350437 ↗
  • InjuryFeb 14, 2022Appropriate Device Problem Term/Code Not Available

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 2 MONTHS FROM 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 13523956 ↗
  • InjuryJul 28, 2020Appropriate Device Problem Term/Code Not Available

    THE PATIENT CAME IN REPORTING PAIN. THE SURGEON OBSERVED THAT THE WOUND SITE WAS RED AND OOZING 1 MONTH AFTER THE PRIMARY. THE SURGEON PERFORMED AN I&D AND REVISED THE MEDACTA LINER AND COMPETITOR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Discharge; Erythema; Pain

    MAUDE report 10331238 ↗
  • InjuryDec 20, 2019Appropriate 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 POLY-SWAP ALMOST 9 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Unspecified Infection

    MAUDE report 9502120 ↗
  • InjuryJan 18, 2019Device Dislodged or Dislocated

    THE PATIENT CAME IN, 3 YEARS AND 1 MONTH AFTER PRIMARY SURGERY, DUE TO INTRA-PROSTHETIC DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE MEDACTA CUP, MEDACTA LINER AND ANOTHER COMPANY'S HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: No Code Available

    MAUDE report 8260594 ↗
  • MalfunctionSep 27, 2018Dent in Material

    DURING HEAD/LINER IMPACTION A DIMPLE WAS GENERATED ON THE LINER. THE SURGEON SWAPPED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 5 MINUTES OF DELAY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7914098 ↗
  • InjuryFeb 23, 2018Appropriate Device Problem Term/Code Not Available

    THE PATIENT CAME IN DUE TO SIGNS OF HEMATOMA 10 DAYS AFTER SURGERY. THE SURGEON REVISED THE HEAD AND LINER.

    Patient problems: Hematoma

    MAUDE report 7292097 ↗

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

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Sources and updates

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