G7 ACETABULAR SCREW 010001003Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
All models of G7 ACETABULAR SCREW (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304527515), received between Nov 30, 2023 and Mar 10, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth2
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Off-Label Use1
Patient problems
- Failure of Implant1
- Fall1
- Joint Dislocation1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 10, 2025Fracture; Off-Label Use; Fracture; Off-Label Use
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 21559430 ↗InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT APPROXIMATELY TWO AND A HALF YEARS POST-IMPLANTATION WITH A COMPETITOR STEM AND HEAD, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO INFECTION AND LOOSENING OF THE CUP. SPACERS WERE IMPLANTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20390333 ↗InjuryNov 30, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT WAS BORN WITH HIP DYSPLASIA. THE PATIENT¿S CUP STARTED TO WEAR AND WAS REVISED. ONE YEAR POST IMPLANTATION, THE PATIENT FELL, AND THE CUP WAS FOUND TO BE LOOSE. THE SURGEON RECOMMENDED A CUSTOM IMPLANT.
Patient problems: Fall
MAUDE report 18243115 ↗
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 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® 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
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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