G7 Acetabular Liner 010000820Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304526105), received between Apr 11, 2022 and Sep 14, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A REVISION OF UNKNOWN DEVICES, THE DOCTOR NOTED THAT THE ACETABULUM WAS NOT PREPARED CORRECTLY; THEREFORE, INSERTED THE CUP WITH FIXATION OF FOUR SCREWS. DURING THE ATTEMPTS OF REDUCTION, ENCOUNTERED DIFFICULTY AND UPON DELIVERY OF FORCE, LED TO ROTATION OF THE PRESS-FIT FEMORAL STEM. A CURVED STEM WAS THEN PLACED AND AS ADDITIONAL REDUCTION ATTEMPTS WERE MADE, THE STEM ALSO ROTATED, LEADING TO THE STEM BEING CEMENTED. IN THE PROCESS OF TESTING THE HIP, ONE EVENT OF DISLOCATION OCCURRED; THEREFORE, ADDITIONAL REDUCTION MANEUVERS WERE REPEATED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS TRANSPORTED OUT OF THE OR. AFTER APPROXIMATELY 1 HOUR, THE PATIENT WAS RETURNED TO THE OR DUE TO DISLOCATION. THE LINER WAS REVISED TO A FREEDOM LINER AND WAS SUCCESSFULLY REDUCED WITHOUT DISLOCATION. SUBSEQUENTLY, DUE TO THE USE OF TENSILE FORCE, THE CUP DETACHED FROM THE ACETABULAR WALL AND THE PATIENT WAS HOSPITALIZED HIP PENDENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 17744748 ↗
• MalfunctionSep 19, 2022Difficult to Insert; Difficult to Insert

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15451248 ↗
• MalfunctionApr 11, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN INITIAL HIP REPLACEMENT SURGERY, THE LINER CAME LOOSE. THE LINER WAS IMPLANTED FLUSH WITH THE RIM. AN IMPACTOR SIZE 36 MM WAS USED. WHEN DOING A TRIAL WITH A TRIAL HEAD ON THE STEM, THE LINER CAME LOOSE. THE SURGEON OPTED TO OPEN A NEW LINER AND THAT WAS PUT INTO PLACE. A THIRTY (30) MIN DELAY OCCURRED TO EXCHANGE LINERS. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14072761 ↗