G7® 110003454Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00887868462528), received between Feb 21, 2024 and Sep 30, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 18, 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.

• MalfunctionSep 30, 2025Damaged Thread; Damaged Thread

  DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23180166 ↗
• MalfunctionSep 8, 2025Damaged Thread; Damaged Thread

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991182 ↗
• MalfunctionSep 8, 2025Damaged Thread; Damaged Thread

  IT WAS REPORTED THAT THE INSERTER THREADED SHAFTS WERE DEFORMED. THERE WERE GROOVES ON THE THREADS. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991180 ↗
• MalfunctionSep 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE G7 CUPS WERE NOT REMOVED FROM THE CURVED INSERTER. THE RETURNED INSTRUMENT WAS CHECKED AND FOUND TO HAVE A DEFORMED GROOVE ON THE G7 THREAD. THE SURGERY WAS COMPLETED USING A STRAIGHT IMPACTOR. THERE WAS A FIVE (5) MINUTE DELAY FOR AN INSTRUMENT EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976276 ↗
• MalfunctionSep 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE G7 CUPS WERE NOT REMOVED FROM THE CURVED INSERTER. THE RETURNED INSTRUMENT WAS CHECKED AND FOUND TO HAVE A DEFORMED GROOVE ON THE G7 THREAD. THE SURGERY WAS COMPLETED USING A STRAIGHT IMPACTOR. THERE WAS A FIVE (5) MINUTE DELAY FOR AN INSTRUMENT EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976227 ↗
• MalfunctionSep 3, 2025Damaged Thread; Damaged Thread

  NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951612 ↗
• MalfunctionJun 26, 2025Difficult to Insert; Naturally Worn; Damaged Thread; Difficult to Insert; Naturally Worn; Damaged Thread

  IT WAS REPORTED THAT THE CURVED INSERTER THREADED SHAFT IS NOT SCREWING AND UNSCREWING PROPERLY, PROBABLY DUE TO WEAR. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337694 ↗
• MalfunctionMay 20, 2025Separation Failure; Damaged Thread; Separation Failure; Damaged Thread

  IT WAS REPORTED THAT THE CUP THREADS WERE STUCK TO THE INSERTER DURING INSERTION. THE SURGERY WAS COMPLETED USING ANOTHER SHELL AND INSERTER. THE THREADS BECAME DAMAGED FROM THE CUP AND INSERTER IN THE PROCESS OF SEPARATING THE DEVICES AFTER THE PROCEDURE. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056075 ↗
• MalfunctionNov 13, 2024Separation Failure; Damaged Thread; Separation Failure; Damaged Thread

  IT WAS REPORTED THAT DURING A HIP SURGERY AFTER CUP TRIAL USE, THE INSERTER THREADED SHAFT GOT STUCK IN THE CURVED INSERTER. THE INSERTER THREADED SHAFT WAS DEFORMED AFTER CUP TRIAL USE AND COULD NOT BE ATTACHED TO IMPLANT. THEREFORE, THE CUP TRIAL COULD NOT BE REMOVED FROM THE CURVED INSERTER. THE SURGEON TRIED TO REMOVE IT WITH A SCREWDRIVER, BUT IT WAS TOO HARD TO REMOVE. SURGERY WAS COMPLETED USING A STRAIGHT INSERTER. IT WAS REPORTED THAT THERE WERE NO ISSUES FOUND WITH THE CUP TRIAL OR CURVED INSERTER. THE ISSUE WAS WITH THE INSERTER THREADED SHAFT, WHICH WAS REMOVED AFTER THE SURGERY, AND FOUND TO BE DEFORMED. THERE WAS NO ADVERSE IMPACT TO THE PATIENT AND NO MEDICAL INTERVENTIONS. THERE WAS A 05-MINUTE DELAY FOR INSTRUMENT REPLACEMENT. THERE WERE NO CONTRIBUTING CONDITIONS RELATED TO THE EVENT. SURGICAL TECHNIQUE FOR THE PRODUCT WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20672684 ↗
• MalfunctionNov 6, 2024Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623464 ↗
• MalfunctionOct 31, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE G7 THREAD TIP OF THE INSERTER CANNOT BE REMOVED AFTER CUP INSERTION. THERE WAS NO ISSUE REGARDING THE SURGERY. NO KNOWN CONSEQUENCE OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20576914 ↗
• MalfunctionSep 3, 2024Separation Failure; Separation Failure

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126262 ↗
• MalfunctionMay 14, 2024Difficult to Insert; Physical Resistance/Sticking; Difficult to Insert; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE PROCEDURE THE THREADED INSERTER SHAFT WOULD NO ASSEMBLE WITH THE SHELL. THERE WAS NOT HARM OR HEALTH CONSEQUENCES TO THAT PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309265 ↗
• MalfunctionMay 14, 2024Difficult to Insert; Physical Resistance/Sticking; Difficult to Insert; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE PROCEDURE THE THREADED INSERTER SHAFT WOULD NO ASSEMBLE WITH THE SHELL. THERE WAS NOT HARM OR HEALTH CONSEQUENCES TO THAT PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309264 ↗
• MalfunctionMay 14, 2024Difficult to Insert; Physical Resistance/Sticking; Difficult to Insert; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE PROCEDURE THE THREADED INSERTER SHAFT WOULD NO ASSEMBLE WITH THE SHELL. THERE WAS NOT HARM OR HEALTH CONSEQUENCES TO THAT PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19308784 ↗
• MalfunctionMay 14, 2024Difficult to Insert; Physical Resistance/Sticking; Difficult to Insert; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE PROCEDURE THE THREADED INSERTER SHAFT WOULD NO ASSEMBLE WITH THE SHELL. THERE WAS NOT HARM OR HEALTH CONSEQUENCES TO THAT PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19308778 ↗
• MalfunctionMay 14, 2024Difficult to Insert; Physical Resistance/Sticking; Difficult to Insert; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE PROCEDURE THE THREADED INSERTER SHAFT WOULD NO ASSEMBLE WITH THE SHELL. THERE WAS NOT HARM OR HEALTH CONSEQUENCES TO THAT PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19308769 ↗
• MalfunctionMay 14, 2024Difficult to Insert; Physical Resistance/Sticking; Difficult to Insert; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE PROCEDURE THE THREADED INSERTER SHAFT WOULD NO ASSEMBLE WITH THE SHELL. THERE WAS NOT HARM OR HEALTH CONSEQUENCES TO THAT PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19308755 ↗
• MalfunctionFeb 21, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHEN THE SURGEON AND NURSE TRIED TO ATTACH THE G7 CUP TO THE INSERTER, THE THREADS WOULDN'T SCREW INTO THE CUP. ANOTHER INSERTER WAS ATTEMPTED WITH THE SAME ISSUE. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE AFTER SEVERAL ATTEMPTS BUT FOUND IT WAS MORE DIFFICULT THAN USUAL. THE THREADS WERE NOT VISIBILY DAMAGED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18746543 ↗
• MalfunctionFeb 21, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHEN THE SURGEON AND NURSE TRIED TO ATTACH THE G7 CUP TO THE INSERTER, THE THREADS WOULDN'T SCREW INTO THE CUP. ANOTHER INSERTER WAS ATTEMPTED WITH THE SAME ISSUE. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE AFTER SEVERAL ATTEMPTS BUT FOUND IT WAS MORE DIFFICULT THAN USUAL. THE THREADS WERE NOT VISIBLY DAMAGED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18746540 ↗

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.