Active Articulation Dual Mobility Hip SystemRecalls & reported problems across all models

We found 5 models of Active Articulation Dual Mobility Hip System by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Dec 19, 2019 and Mar 22, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Active Articulation Dual Mobility Hip System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 19, 2016Terminated

   Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.

   Z-1025-2017 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Active Articulation Dual Mobility Hip System problems

Active Articulation Dual Mobility Hip System models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Active Articulation™ Dual Mobility Hip System XL-200152

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 recall0 reports
• Active Articulation™ Dual Mobility Hip System XL-200150

  Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
  3 reports
• Active Articulation™ Dual Mobility Hip System XL-200156

  Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
  2 reports
• Active Articulation™ Dual Mobility Hip System XL-200146

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 report
• Active Articulation™ Dual Mobility Hip System XL-200148

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  1 report

Recent Active Articulation Dual Mobility Hip System adverse event reports

The 7 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE HEAD DISENGAGED FROM THE BEARING IN THE PATIENT POST OPERATIVELY. THE SURGEON IS CERTAIN FULL PRESSURE WAS ADDED AND THE HEAD WAS FULLY INSERTED IN THE BEARING. THE BEARING WAS STILL IN THE LINER DURING THE REVISION SURGERY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 18959224 ↗
• MalfunctionNov 24, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12870094 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ENDOSCOPIC PROCEDURE APPROXIMATELY ELEVEN(11) YEARS POST IMPLANTATION TO REMOVE SCAR TISSUE, RELEASE RIGHT HIP FLEXOR TENDON & REMOVE BURSA. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Inflammation; Pain; Scar Tissue

  MAUDE report 12797727 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 12149647 ↗
• InjuryJul 8, 2020Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 10244725 ↗
• InjuryJun 24, 2020Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 10188255 ↗
• InjuryDec 19, 2019Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation; Osteopenia/ Osteoporosis

  MAUDE report 9496120 ↗

Other Biomet Orthopedics, LLC products

• AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
• AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
• Compress Device71 models · 99 reports · 22 recalls
• Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
• Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
• Vanguard Knee System147 models · 306 reports · 13 recalls
• STAGEONE17 models · 0 reports · 18 recalls
• StageOne Select15 models · 2 reports · 15 recalls