G7 ACETABULAR SCREW 010000997Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00880304527454), received between Feb 5, 2020 and Nov 14, 2025 — classified as 8 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (4 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• 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 23554926 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT APPROXIMATELY TEN MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A PELVIC DISCONTINUITY AND MIGRATION OF THE CUP AND SCREWS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 23554859 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ONE WEEK POST IMPLANTATION DUE TO PAIN. RADIOGRAPHIC IMAGING DISPLAYED A BONY ACETABULAR FRACTURE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain; Periprosthetic fracture

  MAUDE report 22563648 ↗
• InjuryOct 8, 2024Adverse 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: Bone Fracture(s)

  MAUDE report 20397701 ↗
• InjuryMay 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY THREE DAYS POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO CUP LOOSENING. THE CUP, SCREWS, LINER, BEARING, AND HEAD WERE REVISED. THE STEM WAS RETAINED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 19386864 ↗
• 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 19331261 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Bacterial Infection

  MAUDE report 16195441 ↗
• 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 15296449 ↗
• MalfunctionApr 11, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCTS WERE FOUND TO BE NONCONFORMING. THE INCOMING INSPECTION TEAM MEMBER FOUND THE SEAL WIDTH WAS LESS THAN THE ACCEPTED TOLERANCE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14078642 ↗
• MalfunctionDec 29, 2021Packaging Problem; Packaging Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13110260 ↗
• MalfunctionAug 31, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  UPON REASSESSMENT OF THE REPORTED EVENT, THE DEVICE WAS DETERMINED TO BE NOT REPORTABLE AS THERE WAS NO BREACH IN STERILITY. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12395947 ↗
• MalfunctionAug 31, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  UPON REASSESSMENT OF THE REPORTED EVENT, THE DEVICE WAS DETERMINED TO BE NOT REPORTABLE AS THERE WAS NO BREACH IN STERILITY. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12395870 ↗
• MalfunctionAug 31, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  UPON REASSESSMENT OF THE REPORTED EVENT, THE DEVICE WAS DETERMINED TO BE NOT REPORTABLE AS THERE WAS NO BREACH IN STERILITY. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12395732 ↗
• MalfunctionAug 31, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12395728 ↗
• MalfunctionJan 27, 2021Packaging Problem; Packaging Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 11236033 ↗
• MalfunctionJul 31, 2020Unsealed Device Packaging; Unsealed Device Packaging

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

  Patient problems: No Patient Involvement

  MAUDE report 10349794 ↗
• MalfunctionJun 26, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED UPON INSPECTION AT THE INCOMING WAREHOUSE, THERE WAS DEBRIS IN THE STERILE PACKAGE. NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10201116 ↗
• MalfunctionFeb 5, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THROUGH INCOMING INSPECTION AT THE WAREHOUSE THAT THE SEAL WIDTH WAS LESS THAN 1/4 INCH (6.35MM). NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9670886 ↗
• MalfunctionFeb 5, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THROUGH INCOMING INSPECTION AT THE WAREHOUSE THAT THE SEAL WIDTH WAS LESS THAN 1/4 INCH (6.35MM). NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9670882 ↗
• MalfunctionFeb 5, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THROUGH INCOMING INSPECTION AT THE WAREHOUSE THAT THE SEAL WIDTH WAS LESS THAN 1/4 INCH (6.35MM). NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9670879 ↗
• MalfunctionFeb 5, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THROUGH INCOMING INSPECTION AT THE WAREHOUSE THAT THE SEAL WIDTH WAS LESS THAN 1/4 INCH (6.35MM). NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9670864 ↗

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-1838-2014 · May 7, 2014 · Terminated
  G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
• Z-1837-2014 · May 7, 2014 · Terminated
  G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.