G7® Acetabular System 110010264Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00887868356025), received between Dec 16, 2021 and Dec 31, 2025 — classified as 13 injuries, 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO THE CUP DISSOCIATING FROM THE ACETABULAR WALL. THE CUP WAS NOT SEATED. ALL COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening

  MAUDE report 23934119 ↗
• InjuryMay 27, 2025Material Erosion; Off-Label Use; Material Erosion; Off-Label Use

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO METALLOSIS. THE PATIENT'S HAD A COMPETITOR HEAD AND STEM IMPLANTED WITH ZIMMER BIOMET'S CUP AND LINER. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Hearing Impairment; High metal ion levels; Metal Related Pathology

  MAUDE report 22091586 ↗
• MalfunctionMar 4, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT WHILE OPENING THE OUTER CARDBOARD BOX, THE IMPLANT PACKAGING WAS FOUND DAMAGED. THERE WERE NO DEFORMITIES IN THE OUTER PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21514829 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INITIAL RIGHT TOTAL HIP ARTHROPLASTY. APPROXIMATELY 2 YEARS LATER THE PATIENT RECEIVED A CORTISONE INJECTION TO THE RIGHT HIP FOR BURSITIS AND PAIN. SYMPTOMS WERE REPORTED AS RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bursitis; Pain

  MAUDE report 20846295 ↗
• InjuryDec 3, 2024Loosening 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 16 MONTHS LATER DUE TO ACETABULAR LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20835991 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED 2 YEARS AND 2 MONTHS POST IMPLANTATION, THE PATIENT WAS GIVEN A CORTISONE INJECTION FOR LEFT HIP BURSITIS. THE BURSITIS WAS LIKELY RELATED TO THE INITIAL PROCEDURE. THERE ARE NO PLANS FOR THE PATIENT TO BE REVISED. ALL DEVICES REMAIN IMPLANTED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bursitis

  MAUDE report 20204430 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST-IMPLANTATION THE PATIENT WAS REVISED DUE TO A FRACTURED ACETABULUM. THE SURGEON STATED THAT ACETABULUM FRACTURE CAUSE IS UNKNOWN BUT MAY HAVE OCCURRED AT THE TIME OF IMPLANTATION AND WENT UNNOTICED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Unequal Limb Length

  MAUDE report 19331250 ↗
• InjuryMay 2, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT APPROXIMATELY SIXTEEN MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO REPORTED FAILURE OF ANY IMPLANTS, BUT THE SURGEON NOTED POSSIBLE MALPOSITION OF THE SHELL AS CONTRIBUTING. THE SHELL, LINER, AND HEAD WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Osteopenia/ Osteoporosis; Pain

  MAUDE report 19228849 ↗
• InjuryMar 25, 2024Unstable; Unstable

  IT WAS REPORTED, THAT A PATIENT IS BEING SCHEDULED FOR A LEFT HIP REVISION. APPROXIMATELY, THREE MONTHS POST IMPLANTATION, DUE TO INADEQUATE FIXATION OF THE CUP AND PAIN. TO DATE, NO PROCEDURE HAS OCCURRED. ATTEMPTS HAVE BEEN MADE. AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 18967148 ↗
• MalfunctionJun 16, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT AFTER IMPLANTING THE MULTIHOLE CUP, THE 10 DEGREE LINER WOULD NOT LOCK INTO THE CUP. ANOTHER LINER WAS ATTEMPTED BUT IT ALSO WOULD NOT LOCK INTO CUP SO THE DOCTOR DECIDED TO CEMENT THE LINER TO THE CUP. THERE IS NO ADDITIONAL INFORMATION AVAIALBLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17142669 ↗
• MalfunctionMay 16, 2023Packaging Problem; Packaging Problem

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16942224 ↗
• MalfunctionNov 23, 2022Separation Failure; Mechanical Jam; Separation Failure; Mechanical Jam

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE HANDLE GOT STUCK ON THE G7 CUP. THERE WAS NO HARM OR INJURY TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852350 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS EXPERIENCING EXCRUCIATING PAIN AT SEVERAL FOLLOW UPS AFTER TOTAL HIP ARTHROPLASTY. THE PATIENT WAS TREATED WITH ANALGESIA AND THE PAIN HAS SINCE RESOLVED. THE DEVICES REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 15510274 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED WOUND DEHISCENCE APPROXIMATELY 3 WEEKS AFTER A HIP REVISION. THE PATIENTS WOUND WAS REOPENED AND PROVIDED FLUXOCACILIN ORAL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Wound Dehiscence

  MAUDE report 15420880 ↗
• InjuryAug 25, 2022Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 2.5 MONTHS POST IMPLANTATION DUE TO A TROCHANTERIC AVULSION FRACTURE AND LOSS OF FIXATION WITH VERTICAL MIGRATION OF THE ACETABULAR CUP. THE STEM REMAINED INTACT AND ALL OTHER COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 15296535 ↗
• InjuryAug 12, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 2 WEEKS POST IMPLANTATION DUE TO THE CUP COMPONENT BEING UNSTABLE. DURING THE SURGERY, THE STEM WAS REMOVED IN ORDER TO WIDEN THE OPERATIVE FIELD AND FOUND TO APPEAR GRAY RATHER THAN WHITE AND SUSPECTED THE COATING WAS PEELING OFF. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 15215811 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bone Fracture(s)

  MAUDE report 13022011 ↗