G7® ACETABULAR LINER 010000982Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304989061), received between Oct 28, 2022 and Feb 5, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K121874); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE METAL RING FELL OFF THE FREEDOM CONSTRAINED LINER DURING IMPACTION. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21314454 ↗
• MalfunctionNov 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 18171494 ↗
• MalfunctionApr 13, 2023Difficult to Insert; Difficult to Insert

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732147 ↗
• InjuryOct 28, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT INITIAL RIGHT TOTAL HIP ARTHROPLASTY. THE PATIENT UNDERWENT A FIRST REVISION APPROXIMATELY FIVE MONTHS LATER DUE TO DISLOCATIONS AND STEM SUBSIDENCE. SUBSEQUENTLY, PATIENT UNDERWENT THE SECOND REVISION APPROXIMATELY 1 YEAR AND 3 MONTHS LATER DUE TO DISLOCATION, PAIN, AND INSTABILITY. THE LINER AND HEAD WERE EXCHANGED WITHOUT COMPLICATIONS. THE STEM AND CUP REMAINED IMPLANTED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 15690175 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121874. One submission often covers many models, so check the product and lot details in each record.

• Z-0007-2023 · Aug 25, 2022 · Open, Classified
  G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
• Z-1837-2014 · May 7, 2014 · Terminated
  G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
• Z-1838-2014 · May 7, 2014 · Terminated
  G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.