G7 Acetabular Liner 010000934Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00880304527096), received between Jun 26, 2020 and Dec 17, 2024 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (5 reports).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LINER DID NOT SEAT INSIDE THE G7 ACETABULUM. THE INITIAL CUP WAS ABLE TO BE IMPLANTED, AND A NEW LINER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20952552 ↗
• InjuryOct 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 20567772 ↗
• MalfunctionDec 11, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LINER WAS LOOSE WHEN INSERTED INTO THE CUP EVEN AFTER ADJUSTMENT AND AN ICE-WATER COLD COMPRESS. ANOTHER LINER WAS USED TO COMPLETE THE SURGERY. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18306188 ↗
• InjurySep 6, 2023Detachment of Device or Device Component; Noise, Audible; Detachment of Device or Device Component; Noise, Audible

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17690118 ↗
• MalfunctionApr 6, 2023Difficult to Insert; Difficult to Insert

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16691569 ↗
• MalfunctionFeb 23, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON IMPLANTED G7 BONEMASTER SHELL, 1 SCREW, HIGH WALL LINER AND THEN A + 10 DEGREE LINER. THE SURGEON IMPLANTED THE CUP, INSERTED 25MM BONE SCREW THEN WENT TO PUT IN HIGH WALL LINER. THERE WAS SOLID IMPACT ON LINER ENGAGEMENT BUT IMMEDIATELY AFTER, THE LINER DISENGAGED. THE SURGEON THOUGHT IT WAS THE SCREW, SO HE REMOVED IT AND THEN PUT IT BACK IN, MAKING SURE IT FULLY SEATED AGAIN. HE THEN ATTEMPTED TO IMPACT LINER FOR A 2ND TIME, AND IT WOULD NOT ENGAGE. HE WAS ASKED TO CHECK SOFT TISSUE IMPINGEMENT AND CHECK THE SCREW AGAIN. THE SURGEON FOLLOWED ALL TIPS/INSTRUCTIONS ON PLACING THE LINER AND SCREW CORRECTLY, AND HE DIDN¿T SEE ANY SOFT TISSUE IMPINGEMENT BUT CLEARED ANY SOFT TISSUE IN VICINITY. HE THEN DECIDED TO REMOVE THE SCREW AND REPLACE THE LINER AND AGAIN, THE LINER INITIALLY ENGAGED AND THEN WHEN TRIALING, IT DISENGAGED A THIRD TIME. THE SURGEON WAS OFFERED TO REPLACE THE LINER WITH A NEW LINER (10 DEGREE) AND HE IMPACTED THAT INTO EXISTING CUP. THE LINER DISENGAGED TWICE MORE UPON TRIALING. THE SURGEON WAS ADVISED TO REMOVE THE CUP AND PUT IN A NEW CUP, WHICH HE DID, AND HE ONCE AGAIN TRIED TO IMPACT EXISTING LINER. THE LINER ONCE AGAIN DISENG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16432681 ↗
• InjuryAug 10, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN INITIAL HIP PROCEDURE THE LINER WOULD NOT SEAT IN THE SHELL. IT WAS NOTED AFTER THE ACETABULUM WAS FIXED TO 49 DURING THE OPERATION, A NO. 50 G7 CUP WAS PLACED AND TWO 15MM SCREWS WERE IMPLANTED. THEN THE LINER OF THE TRIAL WAS INSERTED. THE HANDLE PART USED THE NO. 11 ECHO HANDLE AND THE 36/0 TEST HEAD. THE SURGEON STRUCK THE LINER AFTER CHECKING THE SCREW AT THE BOTTOM OF THE ACETABULUM AND FOUND THE G7 LINER WOULD NOT LOCK. THE SURGEON BEGAN TO CLEAN UP THE CUP SURROUNDING SOFT TISSUE, BONE, FAT, AND ONCE AGAIN, CHECKED WHETHER THE SCREW IS TIGHT. STILL THE LINER WOULD NOT LOCK INTO PLACE, AFTER AN HOUR-LONG REPEATEDLY. A NEW LINER WAS OPENED AND INSERTED SUCCESSFULLY. THE STEM AND HEAD WERE THEN INSERTED TO COMPLETE THE OPERATION. A 60-MINUTE DELAY AND BLOOD LOSS OF 800 ML WAS NOTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12300596 ↗
• InjuryOct 7, 2020Positioning Failure; Positioning Failure

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

  Patient problems: No Code Available

  MAUDE report 10641333 ↗
• InjuryOct 7, 2020Positioning Failure; Positioning Failure

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

  Patient problems: No Code Available

  MAUDE report 10641304 ↗
• InjuryJul 14, 2020Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

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

  Patient problems: Bone Fracture(s)

  MAUDE report 10270889 ↗
• MalfunctionJun 26, 2020Positioning Failure; Positioning Failure

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10200973 ↗