G7 Acetabular Liner 010000895Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304526754), received between Apr 29, 2021 and May 2, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL HIP ARTHROPLASTY, THE LINER WOULD NOT SEAT UPON THE ACETABULAR SHELL. A SECOND INLAY WAS ATTEMPTED AND THE SAME MALFUNCTION OCCURRED. THE ACETABULAR SHELL WAS THEN REMOVED AND ANOTHER SHELL AND LINER WERE IMPLANTED WITHOUT COMPLICATION. THERE WAS A SURGICAL DELAY OF 20-30 MINUTES TO REPLACE THE SHELL AND LINER BUT NO PATIENT IMPACT HAS BEEN REPORTED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16853100 ↗
• 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 16432778 ↗
• MalfunctionApr 29, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY THE LINER WAS NOT SEATING INTO THE CUP. A DELAY OF ONE HOUR WAS REPORTED AND SURGEON HAD TO USE A SIZE LARGER TO BAIL OUT OF THE SITUATION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION WAS PROVIDED FROM THE EVENT AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744540 ↗