G7 STRAIGHT INSERTER THREADED SHAFT 110003452Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00880304551602), received between Mar 25, 2021 and Jun 19, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionJun 19, 2026Fracture

  IT WAS REPORTED THAT THE POSITIONING GUIDE ROD AND THE THREADED INSERTER FOR THE CURVED HANDLE BROKE DURING IMPACTION. LIKELY FROM NORMAL WEAR AND TEAR. 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 25563907 ↗
• MalfunctionFeb 13, 2026Difficult to Insert; Naturally Worn

  IT WAS REPORTED THAT A MODULAR INSERT USED WITH AN INSERTER HANDLE WAS DAMAGED AND COULD NOT FULLY SLIDE DOWN THE HANDLE SHAFT. THERE WAS NO IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331992 ↗
• MalfunctionJan 29, 2026Fracture

  IT WAS REPORTED THAT AFTER ACETABULAR LINER IMPACTION, THE INNER SHAFT OF THE INSTRUMENT SHEARED OFF. ALL FRAGMENTS WERE REMOVED FROM THE STERILE FIELD. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208767 ↗
• MalfunctionNov 6, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE INSERTER AND THREADED SHAFT WOULD NOT COME APART. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23491017 ↗
• MalfunctionNov 5, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THE THREADED SHAFT BECAME STUCK INSIDE THE INSERTER. ATTEMPTS WERE MADE TO REMOVE THE SHAFT BUT WERE UNSUCCESSFUL. 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 23480723 ↗
• MalfunctionAug 18, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22825776 ↗
• MalfunctionOct 15, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE MODULAR INSERTER AND SHAFT ARE DAMAGED. UNABLE TO THREAD AND UNTHREAD SHAFT IN AND OUT OF INSERTER. THE PIECE WAS ASSEMBLED AND WAS NOT ABLE TO BE DISASSEMBLED WITHOUT MUCH FORCE OR POSSIBLE FARTHER DAMAGE. THERE WAS NO IMPACT ON SURGERY. SURGERY WAS COMPLETED WITH ORIGINAL DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452986 ↗
• MalfunctionMay 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE INSERTER BROKE WHILE INSERTING THE CUP. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358239 ↗
• MalfunctionMay 1, 2024Fracture; Damaged Thread; Fracture; Damaged Thread

  IT WAS REPORTED THAT WHEN THE INSERTER WAS EXAMINED AFTER THE CASE, THE THREADS APPEARED WORN. THE THREADS ARE FRACTURED IN TWO PLACES. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19223000 ↗
• MalfunctionMar 7, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE STRAIGHT CUP INSERTER WAS WORN. 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 18859302 ↗
• MalfunctionJul 6, 2023Degraded; Physical Resistance/Sticking; Degraded; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE, THE THREADED INSERTER SHAFT WAS DAMAGED AND UNABLE TO HOLD THE TRIAL, IMPACTOR HEAD AND THEN WAS STUCK UNTO THE INSERTER. THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17265863 ↗
• MalfunctionMay 16, 2023Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16937926 ↗
• MalfunctionDec 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TWO PIECE INSERTER BROKE WHEN IMPACTING CUP. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968128 ↗
• MalfunctionSep 8, 2022Positioning Failure; Naturally Worn; Positioning Failure; Naturally Worn

  IT WAS REPORTED THAT THE MODULAR CUP INSERTER THREADED ADAPTER WOULD NOT SCREW INTO THE CUP AND THE THREADS ON THE SHAFT SEEM TO BE WORN DOWN. NO ADVERSE CONSEQUENCES WERE REPORTED. 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 15383785 ↗
• MalfunctionJun 27, 2022Difficult to Insert; Mechanical Problem; Physical Resistance/Sticking; Difficult to Insert; Mechanical Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE INNER THREADED INSERTER GETS STUCK IN THE OUTER INSERTER. THERE WAS NO REPORTED 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 14831736 ↗
• MalfunctionJun 21, 2022Fracture; Fracture

  IT WAS REPORTED THE PART THAT THREADS INTO THE BALL FROM THE STRAIGHT IMPACTOR BROKE OFF INSIDE OF THE BALL. 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 14757825 ↗
• MalfunctionJan 27, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A HIP PROCEDURE THE CUP INSERTION HANDLE COULD NOT BE LOOSENED FROM CUP. TOMMY BAR WAS USED WITH G7 BALL TIP SCREW DRIVER TO TRY TO RELEASE CUP. G7 BALL DRIVER BROKE AT TIP AND INSERTION HANDLE WAS STILL ATTACHED TO CUP IN PATIENT. WHOLE CONSTRUCT WAS REMOVED. NO ADVERSE EVENTS WERE REPORTED. 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 13368079 ↗
• MalfunctionJul 20, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197302 ↗
• MalfunctionApr 14, 2021Fracture; Fracture

  IT WAS REPORTED DURING A TOTAL HIP ARTHROPLASTY THAT THE STRAIGHT INSERTER THREADED SHAFT WOULD NOT THREAD ONTO THE HEAD. THERE WAS NO DELAY AND PATIENT WAS NOT AFFECTED. THE RETURNED DEVICE SHOWS THE TIP WAS FRACTURED. 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 11665990 ↗
• MalfunctionMar 25, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING TOTAL HIP ARTHROPLASTY THE TRAIL SHELL AND THE STRAIGHT INSERTER SHAFT BECAME CROSS THREADED UPON REMOVAL. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. 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 11567536 ↗

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.