G7® Acetabular System 110010248Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of G7 Acetabular System (42)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887868355929), received between Dec 15, 2023 and Jun 5, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Separation Failure1
Patient problems
- Abscess1
- Failure of Implant1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED A DISTAL WOUND ABSCESS AND WAS RESOLVED WITH ORAL ANTIBIOTICS. ALL IMPLANTS REMAIN IN PLACE WITHOUT FURTHER COMPLICATIONS.
Patient problems: Abscess
MAUDE report 19470509 ↗MalfunctionMay 7, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT THE CUP WAS CROSS THREADED ONTO THE INSERTER HANDLE. THE SURGEON WAS UNABLE TO REMOVE THE CUP FROM THE INSERTER. 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 19262865 ↗InjuryDec 15, 2023Loosening 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 10 MONTHS LATER DUE TO LOOSENING OF THE ACETABULAR COMPONENTS. THE PRIMARY X RAY REPORTEDLY SHOWED THAT THE CUP WAS NEVER SEATED PROPERLY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 18334119 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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.
How reports and recalls are matched · Editorial policy · Report an error on this page