G7 ACETABULAR SCREW 010000998Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00880304527461), received between Aug 25, 2022 and Jun 15, 2026 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (9 reports).

3 other recalls cover devices cleared under the same FDA submission (K121874); they may or may not involve this specific model.

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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A SECOND REVISION DUE TO PAIN. THE PATIENT HAD PREVIOUSLY UNDERGONE A REVISION DUE TO DISLOCATION, AND THE SUBSEQUENT REVISION OCCURRED APPROXIMATELY 7 YEARS AND 9 MONTHS AFTER THE PRIOR REVISION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 25503273 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A SECOND REVISION DUE TO PAIN. THE PATIENT HAD PREVIOUSLY UNDERGONE A REVISION DUE TO DISLOCATION, AND THE SUBSEQUENT REVISION OCCURRED APPROXIMATELY 7 YEARS AND 9 MONTHS AFTER THE PRIOR REVISION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 25502959 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A SECOND REVISION DUE TO PAIN. THE PATIENT HAD PREVIOUSLY UNDERGONE A REVISION DUE TO DISLOCATION, AND THE SUBSEQUENT REVISION OCCURRED APPROXIMATELY 7 YEARS AND 9 MONTHS AFTER THE PRIOR REVISION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 25502935 ↗
• MalfunctionJan 5, 2026Positioning Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON INSERTED CUP, SCREW AND LINER. WHEN REDUCING THE HIP, THE LINER HAD MOVED, WAS NO LONGER SEATED FLUSH. THE SURGEON REMOVED THE LINER TO CONFIRM THE SCREWS WERE FLUSH AND NOT PREVENTING THE LINER FROM BEING FULLY SEATED. THE SCREW WAS REMOVED AND NOT REINSERTED AS CUP WAS WELL FIXATED. A NEW LINER WAS USED, AND IT MATED WITH THE CUP SUCCESSFULLY. THE SURGEON FELT THE LINER WAS BENT DURING REMOVAL AND THERE APPEARED TO BE NO DAMAGE TO THE SCREW. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958666 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 23737308 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

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

  Patient problems: Bone Fracture(s)

  MAUDE report 23554936 ↗
• 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 22411196 ↗
• 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 22411186 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PRIMARY HIP PROCEDURE. THE PATIENT WAS IMPLANTED WITH A COMPETITOR STEM AND A ZIMMER BIOMET ACETABULAR CUP AND LINER. SUBSEQUENTLY, THE PATIENT WAS EXPERIENCING CONSTANT PAIN POST-SURGERY AROUND THE BUTTOCK AREA OF ASSOCIATED HIP REPLACEMENT. THE PATIENT WAS REVISED APPROXIMATELY 4 MONTHS POST-IMPLANTATION DUE TO PAIN. ALL PRODUCTS WERE REMOVED AND REPLACED. THE PATIENT WAS REIMPLANTED WITH A COMPETITOR STEM AND ZIMMER BIOMET HEAD, CUP AND LINER. IT WAS REPORTED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: Pain

  MAUDE report 22185637 ↗
• InjuryApr 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 10 YEARS POST IMPLANTATION, THE PATIENT EXPERIENCED LEFT LATERAL PAIN CONSISTENT WITH TROCHANTER BURSITIS. PATIENT TOOK OVER THE COUNTER MEDICATION (NSAIDS) AND OUTPATIENT THERAPY WERE ADMINISTERED AND THE IMPLANTS REMAIN IMPLANTED. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bursitis; Pain

  MAUDE report 21833121 ↗
• InjuryDec 5, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY FOUR MONTHS POST IMPLANTATION DUE TO A DISSOCIATION AND PERI-PROSTHETIC FRACTURE. THE STEM, LINER, BEARING, AND HEAD WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 20852321 ↗
• InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY TWO AND A HALF YEARS POST-IMPLANTATION WITH A COMPETITOR STEM AND HEAD, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO INFECTION AND LOOSENING OF THE CUP. SPACERS WERE IMPLANTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 20391666 ↗
• InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY TWO AND A HALF YEARS POST-IMPLANTATION WITH A COMPETITOR STEM AND HEAD, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO INFECTION AND LOOSENING OF THE CUP. SPACERS WERE IMPLANTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 20389336 ↗
• InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY TWO AND A HALF YEARS POST-IMPLANTATION WITH A COMPETITOR STEM AND HEAD, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO INFECTION AND LOOSENING OF THE CUP. SPACERS WERE IMPLANTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 20389078 ↗
• InjuryDec 15, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18334127 ↗
• InjuryNov 30, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT WAS BORN WITH HIP DYSPLASIA. THE PATIENT¿S CUP STARTED TO WEAR AND WAS REVISED. ONE YEAR POST IMPLANTATION, THE PATIENT FELL, AND THE CUP WAS FOUND TO BE LOOSE. THE SURGEON RECOMMENDED A CUSTOM IMPLANT.

  Patient problems: Fall

  MAUDE report 18240417 ↗
• InjuryAug 21, 2023Fracture; Fracture

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17583214 ↗
• InjuryJun 21, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT HIP PROCEDURE THAT WAS SUBSEQUENTLY REVISED APPROXIMATELY 12 DAYS LATER DUE TO AN ACETABULAR FRACTURE. IT WAS NOTED IN X-RAYS THAT THE ACETABULAR COMPONENT HAD LOOSENED, AND OSTEOPENIA WAS PRESENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Osteopenia/ Osteoporosis

  MAUDE report 17169583 ↗
• InjuryNov 21, 2022Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth; Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT 10 MONTHS AFTER A LEFT TOTAL ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO GROIN PAIN, LOOSENING AND MIGRATION OF THE ACETABULAR CUP. THE HEAD, LINER, SHELL AND SCREWS WERE ALL PLACED WITHOUT COMPLICATION. THE STEM WAS STABLE AND REMAINED INTACT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 15832941 ↗
• 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 15296493 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121874. One submission often covers many models, so check the product and lot details in each record.

• Z-0007-2023 · Aug 25, 2022 · Open, Classified
  G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
• Z-1837-2014 · May 7, 2014 · Terminated
  G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
• Z-1838-2014 · May 7, 2014 · Terminated
  G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.