G7 OSSEOTI ACETABULAR SHELL 110010249Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304544246), received between May 29, 2025 and May 29, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2025Positioning Failure; Device-Device Incompatibility; Positioning Failure; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE PROCEDURE, THE CUP WAS IMPLANTED WITH THREE SCREWS. A LINER WAS ATTEMPTED TO BE IMPLANTED AND WOULD NOT MATE WITH THE CUP. A SECOND LINER WAS OPENED AND ALSO WOULD NOT MATE WITH THE CUP. TRYING TO PLACE THE LINER RESULTED IN THE CUP LOSING FIXATION. THE SHELL AND SCREWS WERE REMOVED AND A SECOND, LARGER CUP WAS IMPLANTED. THE LINER WOULD STILL NOT MATE WITH THE CUP. A THIRD LINER WAS ABLE TO BE IMPLANTED INTO THE SECOND CUP. 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 22109043 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.