G7 OSSEOTI ACETABULAR SHELL 110010247Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of G7 OSSEOTI ACETABULAR SHELL (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304544222), received between Feb 14, 2022 and Jul 28, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Adverse Event Without Identified Device or Use Problem2
- Detachment of Device or Device Component1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Ambulation or Postural Difficulties1
- Bone Fracture(s)1
- Erythema1
- Insufficient Information1
- Joint Dislocation1
- Pain1
- Unequal Limb Length1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 8 YEARS LATER DUE TO THE LINER DISASSEMBLING. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22629663 ↗InjuryApr 16, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED BY THE PMI GROUP THAT A PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT ON AN UNKNOWN DAY FOR AN UNKNOWN REASON. X-RAYS RECEIVED AND REVIEWED, NOTING LOOSENING OF THE ACETABULAR COMPONENT, SUBSIDENCE OF THE FEMORAL COMPONENT, DISLOCATION OF THE FEMORAL HEAD, AND BONE FRACTURE OF THE ACETABULUM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s); Joint Dislocation
MAUDE report 19116682 ↗InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Erythema; Unspecified Infection
MAUDE report 16985075 ↗InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT ALLEGES THAT THE REPRESENTATIVE PROVIDED THE WRONG SIZE HIP TO BE IMPLANTED. PATIENTS ONE LEG IS LONGER THAN THE OTHER LEAVING THE PATIENT UNABLE TO WALK PROPERLY OR ENGAGE IN MOST ACTIVITIES WITHOUT PAIN. NO REVISION HAS BEEN REPORTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Ambulation or Postural Difficulties; Pain; Unequal Limb Length
MAUDE report 13523083 ↗
Other Hip, semi-constrained, cemented, metal/polymer + additive, cemented devices
- G7® Acetabular System 010000664Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented20 reports
- G7 ACETABULAR SCREW 010000999Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented19 reports
- G7® Acetabular System 110010245Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented19 reports
- G7 Acetabular Liner 010000850Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented15 reports
- G7® Acetabular System 010000661Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented13 reports
- G7® Acetabular System 110010242Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented13 reports
- G7 Acetabular Liner 010000937Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented1 death12 reports
- G7 OSSEOTI ACETABULAR SHELL 110010243Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented10 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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