Double Mobility Liner 01.26.2852MRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030807336), received between Nov 22, 2017 and Feb 26, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K083116); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD SIGNIFICANT LEG DISCREPANCY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED HEAD AND LINER AT ABOUT 16 YEARS AFTER PRIMARY AND CHECKED THE STEM AND CUP TO ENSURE THEY WERE STABLE AND HAD NOT BECOME LOOSE. IT IS UNCLEAR WHAT MAY HAVE CONTRIBUTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unequal Limb Length

  MAUDE report 24454888 ↗
• InjuryOct 15, 2024Material Integrity Problem; Material Integrity Problem

  REVISION SURGERY DUE TO SUSPECTED PE HC LINER AND CERAMIC HEAD WEAR, AT ABOUT 14 YEARS 10 MONTHS. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 20448874 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem

  11 YEARS AND 11 MONTHS AFTER PRIMARY THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND ADDED A SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 12142141 ↗
• InjuryOct 5, 2018Adverse Event Without Identified Device or Use Problem

  DURING A ROUTINE FOLLOW UP VISIT, THE SURGEON NOTICED OSTEOLYSIS ON THE X-RAY 9 YEARS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7938082 ↗
• InjuryMar 28, 2018Material Discolored; Device Contamination with Chemical or Other Material; Naturally Worn

  THE PATIENT CAME IN COMPLAINING OF PAIN AND CLICKING OF THE HIP 8 YEARS AFTER PRIMARY. UPON REMOVAL OF THE LINER THE SURGEON NOTICED A BLACK DOT ON THE OUTSIDE TOP OF THE LINER. THE VISIBLE BLACK DOT ON THE OUTSIDE OF THE LINER EXTENDED THROUGH THE ENTIRE LINER. WHEN THE SURGEON CRACKED IT OPEN, A PIECE OF IT CAME OUT. IT WAS NOT A BLOOD CLOT. THERE WAS VISIBLE WEAR AT THE APEX OF THE INSIDE OF THE LINER WHICH WAS A YELLOWISH COLOR AND THE REST OF THE LINER WAS WHITE. THE SURGEON IMPLANTED A MEDACTA LINER WITH ANOTHER COMPANY'S HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE AGENT REPORTED THAT SURGEON SAID IT SOUNDED LIKE TRUNNIONOSIS. ESPECIALLY DUE TO THE FACT THE HEAD AND STEM WERE MISMATCHED COMPANIES. NOTE: ANOTHER COMPANY'S STEM USED IN PRIMARY.

  Patient problems: Pain

  MAUDE report 7377661 ↗
• InjuryNov 22, 2017Device Operates Differently Than Expected

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE PATIENT PRESENTED WITH EARLY STAGE OSTEOLYSIS AROUND THE PROXIMAL PORTION OF THE FEMUR. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Osteolysis; Pain

  MAUDE report 7052727 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083116. One submission often covers many models, so check the product and lot details in each record.

• Z-2709-2011 · May 23, 2011 · Terminated
  Product Brand Name: Versafitcup Double Mobility Liner Inserter Product Generic Name: Versafitcup Double Mobility Liner Inserter Model Number: 01.26.10.0018 The hip prosthesis is
• Z-0878-2013 · Jan 15, 2010 · Terminated
  Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.