G7 OSSEOTI ACETABULAR SHELL 110010269Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304544444), received between Jan 19, 2022 and Dec 6, 2024 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).
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
- Loosening of Implant Not Related to Bone-Ingrowth2
- Detachment of Device or Device Component1
- Migration1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Failure of Implant1
- Insufficient Information1
- Osteopenia/ Osteoporosis1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 19 MONTHS LATER DUE TO ACETABULAR LOOSENING. IT WAS REPORTED THAT NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20864249 ↗MalfunctionOct 7, 2024Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING A REVISION OF ZIMMER BIOMET PRODUCTS, THE INNER PACKAGING HAD MELTED, MAKING IT IMPOSSIBLE TO UNPACK THE PRODUCT. NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20383072 ↗InjuryMay 21, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19360144 ↗InjuryAug 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: Failure of Implant
MAUDE report 17539482 ↗InjuryJan 19, 2022Migration; Migration
IT WAS REPORTED PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 2 MONTHS¿ POST IMPLANTATION DUE TO MIGRATION OF THE ACETABULAR COMPONENT ON RADIOGRAPHS AND NEW ONSET OF PAIN CONSISTENT WITH MECHANICAL LOOSENING. DURING THE REVISION, TWO CUPS WERE PLACED WITH AUGMENTS AND CEMENT TO CREATE ONE CONSTRUCT. A DUAL MOBILITY WAS PLACED, AND THE COMPETITOR STEM WAS RETAINED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteopenia/ Osteoporosis; Pain
MAUDE report 13289115 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.