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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- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
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- 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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