Double Mobility Liner 01.26.2848MRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030807237), received between Oct 31, 2017 and Dec 11, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 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 13 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18301138 ↗
• InjurySep 11, 2019Inadequacy of Device Shape and/or Size

  THE PATIENT CAME IN, 9 YEARS AND 10 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF INSTABILITY DUE TO A LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE MEDACTA LINER AND THE COMPETITOR'S HEAD. MEDACTA CUP AND COMPETITOR'S STEM ARE STILL IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8987625 ↗
• InjuryMay 23, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY ABOUT 9 YEARS AND 10 MONTHS AFTER PRIMARY DUE TO GENERIC PAIN. THE REASON OF PAIN IS UNKNOWN. CUP AND STEM LOOKED WELL FIXED. THE SURGERY WAS COMPLETED SUCCESSFULLY, HEAD AND LINER SWAPPED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 8636448 ↗
• InjuryApr 30, 2019Insufficient Device Problem Information

  HIP REVISION SURGERY 10 YEARS AFTER PRIMARY. THE REASON OF REVISION IS UNKNOWN AT THE MOMENT BECAUSE WE RECEIVED DIFFERENT EVENT DESCRIPTION FROM THE AGENT AND FROM (B)(4). ONLY CUP HAS BEEN REVISED. MORE INFO WILL FOLLOW THIS CASE.

  Patient problems: No Code Available

  MAUDE report 8564988 ↗
• InjuryApr 2, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY 9.5 YEARS AND A HALF AFTER PRIMARY FOR OSTEOLYSIS. THE SURGEON REVISED CUP AND LINER SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8473652 ↗
• InjuryAug 17, 2018Material Deformation

  THE PATIENT COMPLAINED HIP PAIN 3 YEARS AFTER THE PREVIOUS SURGERY. THE SURGEON REVISED SUCCESSFULLY THE LINER AND THE HEAD. A PREMATURE LINER WEAR AND DEFORMATION WAS DETECTED.

  Patient problems: Pain

  MAUDE report 7793272 ↗
• InjuryJan 3, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO PAIN CAUSED BY AN INFLAMMATION AROUND THE JOINT AFTER 7 YEARS AND 9 MONTHS FROM THE PRIMARY. THE SURGEON REVISED HEAD AND LINER.

  Patient problems: Pain

  MAUDE report 7160295 ↗
• InjuryOct 31, 2017Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE STEM AND CUP WERE WELL FIXED. THE SURGEON DECIDED TO DO JUST A HEAD-LINER EXCHANGE. OSTEOLYSIS WAS CONFIRMED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Osteolysis; Pain

  MAUDE report 6990403 ↗

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.