G7® 110003450Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
Quick summary
This is a Biomet hip replacement cup used in hip arthroplasty. The 29 reports mostly describe inserter handles and shells that would not thread properly, stripped or broken threads, and parts deforming or fracturing during surgery, sometimes forcing the team to switch to another handle. Two injuries and no deaths were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00887868462481), received between Aug 2, 2023 and Jun 10, 2026 — classified as 2 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Damaged Thread” (8 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Damaged Thread8
- Difficult to Insert7
- Material Deformation5
- Fracture4
- Physical Resistance/Sticking3
- Separation Failure3
- Difficult to Remove2
- Mechanical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions29
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2026Difficult to Insert; Damaged Thread
IT WAS REPORTED, DURING A CASE, THE NURSE HAD TROUBLE PUTTING FINAL CUP ON STRAIGHT HANDLE IMPACTOR, TO REALIZE, THE THREADS WERE DAMAGED. SURGERY WAS COMPLETED WITH OTHER HANDLE ALREADY ON STERILE TABLE, NO DELAY. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25461672 ↗MalfunctionDec 30, 2025Damaged Thread; Damaged Thread
IT WAS REPORTED THE THREADS ON A MONOBLOCK CUP INSERTER BROKE. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927889 ↗MalfunctionDec 18, 2025Difficult to Insert; Damaged Thread; Difficult to Insert; Damaged Thread
IT WAS REPORTED THAT THE INSERTER HANDLE TIP IS STRIPPED AND CANNOT THREAD ONTO THE SHELL PROPERLY. 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 23838276 ↗MalfunctionSep 4, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22967336 ↗InjurySep 3, 2025Separation Failure; Physical Resistance/Sticking; Damaged Thread; Separation Failure; Physical Resistance/Sticking; Damaged Thread
UPON RECEIPT OF ADDITIONAL INFORMATION, THE PREVIOUSLY REPORTED EVENT WAS FOUND TO BE A DUPLICATE COMPLAINT ENTRY. THE EVENT HAS BEEN REPORTED UNDER 0001825034-2025-02673.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22956738 ↗MalfunctionAug 25, 2025Separation Failure; Physical Resistance/Sticking; Damaged Thread; Separation Failure; Physical Resistance/Sticking; Damaged Thread
NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22885594 ↗MalfunctionJul 15, 2025Fracture; Fracture
IT WAS REPORTED THAT THE SHELL INSERTER WAS FOUND BROKEN IN THE TRAY AND COULD NOT BE SCREWED TO THE CUP. ANOTHER HANDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. IT WAS REPORTED NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22506009 ↗MalfunctionMay 12, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE INSERTER HANDLE WOULD NOT THREAD ONTO THE NEW SHELL. THE SHELL WAS SUCCESSFULLY INSERTED WITH ANOTHER HANDLE. 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 22005321 ↗InjuryApr 15, 2025Damaged Thread; Damaged Thread
IT WAS REPORTED THAT THE THREADS ON THE G7 MONOBLOCK STRAIGHT IMPACTOR WERE NOTICED TO BE DAMAGED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21842305 ↗MalfunctionFeb 5, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21315752 ↗MalfunctionSep 3, 2024Difficult to Insert; Difficult to Insert
IT WAS REPORTED THE CUP INSERTER WOULD NOT THREAD PROPERLY. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE CASE. 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 20127582 ↗MalfunctionAug 26, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SURGEON COULD NOT DISENGAGE NON-MODULAR INSERTER FROM THE G7 SHELL, SURGEON CLAIMS THE THREADS OF THE INSERTER ARE SLIGHTLY DAMAGED. THE SURGERY WAS COMPLETED WITH A NEW SHELL AND INSERTER. THE SURGICAL TECHNIQUE OF THE PRODUCTS WAS UTILIZED. A MINOR DELAY TOOK PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20065715 ↗MalfunctionJul 16, 2024Damaged Thread; Damaged Thread
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19752774 ↗MalfunctionJul 10, 2024Damaged Thread; Damaged Thread
IT WAS REPORTED THAT DURING THE PROCEDURE, THE INSERTER HANDLE WAS CROSS THREADED WITH THE SHELL. THE SHELL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19710857 ↗MalfunctionJul 5, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE IMPACTOR THREADS WERE DAMAGED WHICH LED TO DAMAGED MONOBLOCK G7 IMPACTOR. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19679179 ↗MalfunctionApr 17, 2024Difficult to Insert; Naturally Worn; Difficult to Insert; Naturally Worn
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19124842 ↗MalfunctionApr 9, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT WHEN THE SURGEON WAS IMPLANTING THE ACETABULAR SHELL INTO THE PATIENT, THE STRAIGHT HANDLE CUP INSERTER WOULD NOT UNSCREW FROM THE SHELL. THE PROCEDURE WAS COMPLETED USING A NEW INSERTER AND IMPLANT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19075599 ↗MalfunctionApr 9, 2024Mechanical Problem; Mechanical Problem
NO ADDITIONAL EVEN INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19070557 ↗MalfunctionMar 28, 2024Fracture; Material Deformation; Fracture; Material Deformation
IT WAS REPORTED DURING SURGERY THAT THE LAST THREAD ON THE G7 INSERTER BROKE OFF FROM WEAR. THERE WAS NO REPORTED HARM OR IMPACT TO THE PATIENT. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18994751 ↗MalfunctionFeb 5, 2024Difficult to Remove; Difficult to Remove
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18640471 ↗MalfunctionDec 29, 2023Mechanical Jam; Mechanical Jam
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18418144 ↗MalfunctionDec 18, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED DURING THE HAMMERING OF THE SHELL, IT WAS IMPOSSIBLE TO UNSCREW THE SHELL FROM THE IMPACTOR. NO KNOWN 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 18344534 ↗MalfunctionDec 16, 2023Difficult to Remove; Difficult to Remove
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18341600 ↗MalfunctionDec 15, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT WHILE PREPARING FOR THE CASE, THE THREADS ON THE CUP INSERTER WERE FOUND TO BE DAMAGED AND WOULD NOT WORK. ANOTHER INSERTER WAS USED TO COMPLETE THE CASE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18334649 ↗MalfunctionDec 1, 2023Difficult to Insert; Difficult to Insert
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18247467 ↗
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, ClassifiedG7 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 · TerminatedG7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
- Z-1838-2014 · May 7, 2014 · TerminatedG7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
Other prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive devices
- G7® Acetabular System 010000665Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive31 reports
- G7® Acetabular System 110010244Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive24 reports
- G7® Acetabular System 110010263Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive11 reports
- G7 CURVED INSERTER THREADED SHAFT 110003454Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive9 reports
- G7® Acetabular System 110010266Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive9 reports
- G7 OSSEOTI ACETABULAR SHELL 110010265Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive7 reports
- G7® 110010717Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive7 reports
- G7 Acetabular Liner 010000927Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive6 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.