G7 OSSEOTI ACETABULAR SHELL 110010265Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304544406), received between Jan 20, 2020 and Aug 26, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2025Unintended Movement; Noise, Audible; Unintended Movement; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SNAPPING IN THE HIP APPROXIMATELY TWO YEARS POST-IMPLANTATION. IT WAS CONFIRMED THAT THE PATIENT HAD ILIOPSOAS TENDINITIS CAUSED BY IMPINGEMENT. PATIENT WAS REFERRED FOR AN INJECTION UNDER FLUOROSCOPY. FOLLOW- UPS TO GATHER ADDITIONAL INFORMATION ARE CURRENTLY IN PROCESS.

  Patient problems: Joint Impingement; Pain; Tendinopathy

  MAUDE report 22893032 ↗
• InjuryJul 7, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 2 YEARS LATER DUE TO ACETABULAR LOOSENING. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening

  MAUDE report 22411183 ↗
• InjuryApr 4, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 14 MONTHS POST IMPLANTATION DUE TO A LOOSE ACETABULAR COMPONENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19041703 ↗
• MalfunctionMar 5, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE CUP IMPACTOR WOULD NOT THREAD INTO THE CUP. THE THREADS TO THE INSERTER WERE STRIPPED AND THE CUP APPEARED TO BE DAMAGED. NO PATIENT INVOLVEMENT REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837638 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO PAIN AND METAL RELATED PATHOLOGY APPROXIMATELY 7 YEARS POST IMPLANTATION. SUBSEQUENTLY, THE PATIENT VISITED THE EMERGENCY ROOM DUE TO DISLOCATIONS, PAIN AND SWELLING WITH NO NOTED MEDICAL INTERVENTION. THE PATIENT THEN UNDERWENT A SECOND REVISION APPROXIMATELY 4 YEARS LATER DUE TO CHRONIC INFECTION. ALL DEVICES WERE REMOVED AND REPLACED WITH SPACERS. APPROXIMATELY 1 MONTH LATER THE PATIENT STILL HAD ONGOING INFECTION DESPITE USE OF ANTIBIOTICS, SO NEW SPACERS WERE IMPLANTED ALONG WITH WIRES. THERE IS NO REPORT OR NEW PERMANENT IMPLANTS BEING IMPLANTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Osteopenia/ Osteoporosis; Scar Tissue; Sepsis

  MAUDE report 12432259 ↗
• MalfunctionJun 8, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED DURING SURGERY, THE LINER WOULD NOT ASSEMBLE WITH THE ACETABULAR SHELL. THIS SURGERY WAS FINISHED WITH BACKUP PRODUCT. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10130777 ↗
• MalfunctionJan 20, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY, THE G7 CUP INTRODUCER WAS DAMAGED AND THE G7 CUP WAS STUCK ON THE INTRODUCER AND UNABLE TO GET IT OFF AT THE TIME OF SURGERY. THE G7 INTRODUCER AND G7 CUP DISCARDED AND ALTERNATIVE INTRODUCER AND NEW G7 CUP WAS USED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9608482 ↗