G7 CURVED INSERTER THREADED SHAFT 110003454Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00880304543331), received between Jul 8, 2021 and Sep 8, 2025 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Damaged Thread2
- Positioning Failure2
- Difficult to Insert1
- Material Deformation1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2025Fracture; Naturally Worn; Fracture; Naturally Worn
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22991160 ↗MalfunctionSep 5, 2025Damaged Thread; Damaged Thread
IT WAS REPORTED WHEN ATTEMPTING TO SCREW THE CUP INTO THE CURVED HANDLE THE BLACK SCREW DID NOT SCREW OR UNSCREW PROPERLY. THE SURGEON STATED THAT THE CUP WAS LOOSE ON THE HANDLE. THE SURGERY WAS COMPLETED WITH A SECOND SCREW IN THE SET. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22982229 ↗MalfunctionFeb 21, 2025Damaged Thread; Damaged Thread
IT WAS REPORTED THAT DURING SURGERY, THE THREADED INSERTER SHAFT WOULD NOT ATTACH TO THE CUP AS GROOVES WERE COLLAPSED AND NARROWED. 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 21433797 ↗MalfunctionJan 23, 2025Material Deformation; Material Deformation
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21216252 ↗MalfunctionAug 9, 2023Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17486607 ↗MalfunctionJan 4, 2023Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE THREADED SHAFT IS COMING LOOSE FROM THE CUP. THERE WAS 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 16094525 ↗MalfunctionJan 4, 2023Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE THREADED SHAFT IS COMING LOOSE FROM THE CUP. THERE WAS 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 16094522 ↗MalfunctionDec 29, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED THE INSERTERS CAME LOOSE FROM THE CUP. NO PATIENT INVOLVEMENT. DUE DILIGENCE HAS BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16068397 ↗MalfunctionJul 8, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12134388 ↗
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-1838-2014 · May 7, 2014 · TerminatedG7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
- Z-1837-2014 · May 7, 2014 · TerminatedG7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
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® 110003450Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive29 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® Acetabular System 110010266Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive9 reports
- G7® 110010717Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive7 reports
- G7 OSSEOTI ACETABULAR SHELL 110010265Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive7 reports
- G7 Acetabular Liner 010000926Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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