G7 OSSEOTI ACETABULAR SHELL 110010243Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00880304544185), received between Jul 6, 2020 and Jul 22, 2025 — classified as 6 injuries, 4 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Detachment of Device or Device Component1
- Difficult to Remove1
- Migration1
- Physical Resistance/Sticking1
- Positioning Failure1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Pain3
- Bursitis1
- Cellulitis1
- Failure of Implant1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
- Periprosthetic fracture1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ONE WEEK POST IMPLANTATION DUE TO PAIN. RADIOGRAPHIC IMAGING DISPLAYED A BONY ACETABULAR FRACTURE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain; Periprosthetic fracture
MAUDE report 22563641 ↗InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. AT 2 YEARS POSTOP, THE PATIENT REPORTS ONGOING MODERATE LOW BACK PAIN THAT WAS NOT PRESENT PRIOR TO THE INITIAL PROCEDURE. IT WAS INITIALLY THOUGHT TO BE GENERAL POSTOP SORENESS, BUT THE PAIN HAS NOT RESOLVED AND CONTINUES TO LIMIT DAILY ACTIVITIES. THE PATIENT HAS STARTED THERAPY FOR THE LOW BACK PAIN, TAKES NSAIDS FOR PAIN, AND USES A CANE FOR LONG DISTANCES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain
MAUDE report 22284953 ↗MalfunctionMay 9, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE TRILOGY SCREW WENT THROUGH THE G7 50MM CUP. 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 21992611 ↗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 19075718 ↗InjuryFeb 20, 2024Migration; Migration
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18739371 ↗InjuryOct 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 17897400 ↗MalfunctionJul 14, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17325096 ↗InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IS SCHEDULE FOR A REVISION APPROXIMATELY FOUR YEARS POST IMPLANTATION FOR UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 17163166 ↗InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS SEEN FOR BURSITIS AND TREATED WITH FORMAL PHYSICAL THERAPY AND OVER THE COUNTER TOPICAL CREAM FOR ONGOING PAIN. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bursitis; Cellulitis; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 16918476 ↗MalfunctionJul 6, 2020Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE SURGICAL STAFF COULD NOT REMOVE THE CENTER SCREW CAP ON ACETABULAR CUP. AFTER MULTIPLE ATTEMPTS TO REMOVE THE CENTER SCREW CAP THE DRIVE PORTION OF THE CUP WAS ROUNDED OUT AND FURTHER ATTEMPT TO REMOVE THE CAP WERE ABANDONED. A SECOND ACETABULAR CUP OF THE SAME SIZE WAS OPENED AND IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10237582 ↗
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 System 110010245Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented19 reports
- G7 ACETABULAR SCREW 010000999Biomet 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 110010242Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented13 reports
- G7® Acetabular System 010000661Biomet 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® Vivacit-E® 30123204Zimmer, Inc. · Hip, semi-constrained, cemented, metal/polymer + additive, cemented8 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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