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
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
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page