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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 1 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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 ↗

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Sources and updates

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