Double Mobility Liner 01.26.2852MHCRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 07630030807343), received between Feb 16, 2018 and May 13, 2026 — classified as 33 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (4 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AFTER 1 MONTH FROM THE PRIMARY DUE TO INFECTION. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER TO A SAME SIZE LINER, AND REVISED THE HEAD TO A SAME SIZE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25160343 ↗
• MalfunctionMay 12, 2026Device Dislodged or Dislocated

  THE PATIENT UNDERWENT PRIMARY LEFT HIP SURGERY WITH A CUSTOM ACETABULAR CUP ON (B)(6) 2026, UNDER COMPASSIONATE USE. APPROXIMATELY THREE WEEKS LATER, THE PATIENT EXPERIENCED A DISLOCATION OF THE LINER FROM THE HEAD AFTER A TWISTING MOVEMENT. THE DISLOCATION WAS MANUALLY REDUCED WITHOUT THE USE OF ANESTHESIA.

  Patient problems: Joint Dislocation

  MAUDE report 25148978 ↗
• InjuryMay 12, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2026, THE PATIENT HAD A MEDACTA D 28/DMF LINER AND D 52 MM VERSACEM METALBACK CUP IMPLANTED. ON (B)(6) 2026, THE PATIENT HAD HIP INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER TO A SAME SIZE LINER AND REVISED THE D 52 CUP TO A D 56 MM CUP AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25148953 ↗
• InjuryJun 6, 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 1 WEEK 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 22157481 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO DEVELOPING A HEMATOMA AND THE CAUSE IS UNKNOWN. ABOUT 1 WEEK AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hematoma; Pain

  MAUDE report 21504504 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING GROWING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 21354696 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 MONTHS AFTER 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: Medical device site infection

  MAUDE report 21208403 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 20 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 18139897 ↗
• InjuryNov 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY FOR INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 6 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18055000 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SOFT TISSUE IMPINGEMENT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE COMPETITOR HEAD AND MEDACTA LINER (SAME SIZE). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 18028311 ↗
• InjuryAug 9, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY COMPETITOR HIP SURGERY ON AN UNKNOWN DATE. ON (B)(6) 2021, THE PATIENT CAME IN FOR UNKNOWN REASONS AND HAD A PARTIAL REVISION TO A MEDACTA STEM, HEAD AND LINER THAT WAS MATCHED TO THE INTERNAL DIAMETER OF THE EXISTING ACETABULAR IMPLANT FROM THE INITIAL RESURFACING SURGERY. ON (B)(6) 2023, THE PATIENT CAME IN DUE TO THE DEVELOPMENT OF A PSEUDO TUMOR THAT FORMED IN THE PELVIS, BEHIND THE ACETABULAR IMPLANT. THE SURGEON REVISED THE COMPETITOR CUP AND MEDACTA STEM, HEAD AND LINER TO ALL NEW MEDACTA COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. NOTE: IT HAS BEEN REPORTED THAT THERE WERE NO ISSUES WITH MEDACTA IMPLANTS, THE SURGEON NEEDED TO REMOVE EVERYTHING TO GAIN EXPOSURE TO THE TUMOR.

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

  MAUDE report 17486504 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 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, REMOVED THE STEM, HEAD AND LINER, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17441293 ↗
• InjuryMar 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY FOR INFECTION 1 YEAR AND 10 MONTHS POST PRIMARY FOR INFECTION. LINERS AND HEAD REVISED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16520701 ↗
• InjuryJun 10, 2022Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2022, PATIENT HAD A PRIMARY LEFT HIP SURGERY AND ON (B)(6) 2022 HE HAD A PRIMARY RIGHT HIP SURGERY. ON (B)(6) 2022 THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO SIGNS OF INFECTION. THE SURGEON PERFORMED A BILATERAL REVISION SURGERY AND REVISED HEADS AND LINERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14652253 ↗
• InjuryNov 4, 2021Adverse Event Without Identified Device or Use Problem

  AT 2 WEEKS 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 POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12750918 ↗
• InjuryJul 1, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 9 DAYS AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12098419 ↗
• InjuryApr 9, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 1 MONTH AFTER THE PRIMARY SURGERY 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. 4 DAYS AFTER THE 1ST REVISION SURGERY, FOLLOWING AN INFECTION (UNKNOWN PATHOGEN), THE SURGEON PERFORMED A WASHOUT AND DID NOT REVISE ANY COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 11640107 ↗
• InjuryMar 4, 2021Loose or Intermittent Connection

  THE PATIENT HAD PRIMARY HIP SURGERY ON (B)(6) 2018. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. STEM AND HEAD WERE REVISED WITH COMPETITOR PRODUCTS AND MEDACTA LINER WAS REVISED WITH A MEDACTA LINER. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND IMPLANTED AN ANTIBIOTIC SPACER, 1 MONTH AFTER THE PREVIOUS SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11410384 ↗
• InjuryFeb 12, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 2 MONTHS AFTER THE PRIMARY SURGERY 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 11321528 ↗
• InjuryDec 28, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, 5 MONTHS AFTER PRIMARY SURGERY, 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 11075684 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN AFTER 1 MONTH FROM THE PRIMARY SURGERY 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 11037519 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, 1 MONTH AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10748130 ↗
• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 MONTH AFTER THE PRIMARY SURGERY 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 10668667 ↗
• InjurySep 9, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, LINER, CUP, AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10507104 ↗
• InjuryMay 15, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 1 YEAR AND 8 MONTHS AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT, REVISED THE MEDACTA MPACT DM LINER AND THE COMPETITOR FEMORAL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10060446 ↗