G7 OSSEOTI ACETABULAR SHELL 110010244Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304544192), received between Apr 10, 2020 and Apr 3, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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. How this data works · Data updated Oct 13, 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.

• InjuryApr 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT APPROXIMATELY EIGHT YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO PAIN AND LOOSENING OF THE CUP FROM ACETABULAR BONE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Failure of Implant; Pain

  MAUDE report 21761221 ↗
• MalfunctionJan 26, 2024Fracture; Fracture

  NO ADDTIIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587678 ↗
• InjuryOct 4, 2023Material Erosion; Adverse Event Without Identified Device or Use Problem; Material Erosion; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bursitis; Cartilage damage; Distress; High metal ion levels; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 17868037 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT DEVELOPED SEVERE PAIN REQUIRING MEDICATION APPROXIMATELY TWO YEARS POST IMPLANTATION. UPON RECEIPT OF THE MEDICATION, THE ISSUE WAS RESOLVED APPROXIMATELY ONE MONTH LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 16983062 ↗
• MalfunctionJun 24, 2022Degraded; Degraded

  IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY, THE SCREW COVERS WERE STRIPPED AND COULDN'T BE REMOVED FROM THE CUP. ANOTHER CUP WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14799332 ↗
• InjuryMay 23, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

  Patient problems: Failure of Implant

  MAUDE report 14469394 ↗
• InjuryApr 10, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A HIP REVISION SURGERY, A CUP WAS IMPLANTED WITHOUT COMPLICATION. TWO DIFFERENT LINERS WERE ATTEMPTED TO BE IMPLANTED WITHOUT SUCCESS. A NEW LINER AND CUP COMBO WERE USED TO COMPLETE THE SURGERY WITH APPROXIMATELY 50 MINUTES OF DELAY IN THE SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Information

  MAUDE report 9947861 ↗