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
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
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- 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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