Double Mobility Liner 01.26.2854MHCRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07630030807381), received between Jul 25, 2018 and Mar 30, 2026 — classified as 25 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.

Most reported problems

Recent adverse event reports

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

• InjuryMar 30, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION ABOUT 2 MONTHS AFTER PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 28 MM BIOLOX HEAD TO A SAME SIZE HEAD AND REVISED THE D 28 DOUBLE MOBILITY LINER TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24711257 ↗
• InjuryAug 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 9 YEARS 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 22894260 ↗
• InjuryJun 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT CAME IN REPORTING OF PAIN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGEON USED ANOTHER COMPANY'S STEM WITH A MEDACTA HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A BROKEN STEM. THE SURGEON REVISED THE COMPETITOR STEM AND REVISED THE MEDACTA HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO THE HEAD DISLOCATING FROM THE VERSAFITCUP DM SHELL. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 22201170 ↗
• InjuryApr 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF 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 21762531 ↗
• InjuryApr 3, 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 6 MONTHS 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 21760522 ↗
• InjuryNov 27, 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. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20798156 ↗
• InjurySep 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY THE SAME DAY OF PRIMARY FOR JOINT LUXATION (LINER DM FROM SHELL). SHELL, HEAD AND LINER REVISED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 20320863 ↗
• InjuryMay 28, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AFTER THE PRIMARY HIP SURGERY, WHEN THE PATIENT WAS IN RECOVERY, IT WAS OBSERVED THAT THE INCORRECT LINER SIZE WAS OPENED AND IMPLANTED IN THE PATIENT. THE PATIENT WAS BROUGHT BACK TO THE OR (THE SAME DAY), THE DM LINER & HEAD WERE REMOVED. THE SURGEON ALSO DECIDED TO EXTRACT THE STEM (4 STD) AND SWITCH IT TO A SIZE 4 LAT. THE SURGERY WAS COMPLETED SUCCESSFULLY. ONE OF THE SALES AGENT REPS HANDED THE IMPLANT TO THE CIRCULATING NURSE WHO OPENED IT ONTO THE FIELD, THE TECH ASSEMBLED THE HEAD AND LINER AND GAVE THE CONSTRUCT TO THE SURGEON.

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

  MAUDE report 19403423 ↗
• InjuryFeb 13, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 1 MONTH 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: Medical device site infection

  MAUDE report 18693812 ↗
• InjuryJan 24, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY PERFORMED DUE TO INFECTION 26 DAYS AFTER THE PRIMARY SURGERY. LINER AND HEAD WERE REPLACED.

  Patient problems: Medical device site infection

  MAUDE report 18569384 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. AT ABOUT 9 MONTHS FROM PRIMARY THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unequal Limb Length

  MAUDE report 18516283 ↗
• InjurySep 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON THE SAME DAY OF THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT LUXATION OF THE HEAD AND THE LINER FROM THE CUP. THE SURGEON REVISED ALL IMPLANTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT HAS BEEN REPORTED THAT THE PATIENT KEPT MOVING HIS LEGS AND IT IS SUSPECTED THAT HE INTENTIONALLY DISLOCATED HIS HIP, IN ORDER TO STAY IN THE HOSPITAL LONGER, INSTEAD OF RETURNING TO PRISON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17697673 ↗
• InjuryDec 19, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PREFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 16004180 ↗
• InjuryOct 27, 2022Osseointegration Problem; Osseointegration Problem

  AT ABOUT 11 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP. THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE HEAD, LINER, AND CUP WITH ADDITIONAL SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15680349 ↗
• InjurySep 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 2 MONTHS FROM THE 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 15483773 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem

  AT 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 POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14683691 ↗
• InjuryMay 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT 3 WEEKS AFTER THE PRIMARY, REVISION SURGERY DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE PATIENT WAS DOING A MOVEMENT BACKWARD WITH THE LEG AND THEN SHE FELL, BUT IT CANNOT SAY IF SHE FELL BECAUSE THE HIP LUXATED OR IF SHE FELL AND THEN THE HIP LUXATED. THE SURGEON REVISED THE LINER AND HEAD (IMPLANTING AN XL INSTEAD OF M). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Fall

  MAUDE report 14485386 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 3 MONTHS AND A HALF AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14250701 ↗
• InjuryMar 24, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING DISCOMFORT DUE TO OSTEOLYSIS THAT DEVELOPED BEHIND THE CUP IMPLANT. THE SURGEON REVISED THE CUP, HEAD, AND LINER ALMOST 3 YEARS AND 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Osteolysis

  MAUDE report 9870993 ↗
• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, ONE MONTH AFTER PRIMARY SURGERY, DUE TO SIGNS OF 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 9580570 ↗
• InjuryNov 18, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 3 YEARS AND 4 MONTHS AFTER THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9334344 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2019. THE PATIENT SUBSEQUENTLY CAME IN ON (B)(6) 2019 DUE TO SIGNS OF AN INFECTION. THE PATHOGEN WAS UNKNOWN AND THE SURGEON (MD CRAIG BONE) REVISED THE HEAD, SLEEVE AND POLY, COMPLAINT (B)(4) [MDR 2019-00757] WAS FILLED. ON THE (B)(6) 2019 ABOUT 1 MONTH AFTER PRIMARY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON PLANS TO IMPLANT PERMANENT HARDWARE IN 6 WEEKS.

  Patient problems: Unspecified Infection

  MAUDE report 9085573 ↗
• InjuryJan 18, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, TWO WEEKS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8260593 ↗
• InjurySep 27, 2018Appropriate Device Problem Term/Code Not Available

  ABOUT 1 MONTH AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR HIP INFECTION. LINER AND HEAD SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7914101 ↗
• InjuryJul 25, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 MONTH AFTER PRIMARY. THE PATHOGEN IS CONFIRMED AS STAPHYLOCOCCUS. THE SURGEON PERFORMED AND I&D AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7718461 ↗