G7 OSSEOTI ACETABULAR SHELL 110010266Recalls & 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 00880304544413), received between Jul 27, 2017 and Dec 3, 2025 — 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
- Insufficient Device Problem Information1
- Packaging Problem1
- Unintended Movement1
Patient problems
- Insufficient Information2
- Ambulation or Postural Difficulties1
- Aseptic loosening1
- Bone Fracture(s)1
- Failure of Implant1
- Muscle/Tendon Damage1
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT UNDERWENT A THIRD LEFT HIP REVISION DUE TO ASEPTIC LOOSENING APPROXIMATELY 8 (EIGHT) MONTHS LATER. DURING THE REVISION, THE CUP WAS FOUND TO BE GROSSLY LOOSE AND REMOVED WITHOUT DIFFICULTY, FEMORAL STEM WAS ALSO NOTED TO BE LOOSE. ALL IMPLANTS WERE REVISED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Pain; Radiolucent Lines
MAUDE report 23711960 ↗InjuryDec 14, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THREE DAYS AFTER A RIGHT HIP REVISION SURGERY, THE PATIENT REQUIRED A SECOND REVISION DUE TO A SCREW PULLING THROUGH THE ACETABULAR SHELL WITH SUBSEQUENT LOOSENING OF THE ACETABULAR SHELL. THE SURGEON REMOVED THE SHELL AND RE-IMPLANTED A NEW SHELL. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY, NO SURGICAL COMPLICATIONS, AND NO FOREIGN BODY WAS RETAINED. IT IS NOT KNOWN WHETHER THE PATIENT'S CONDITION OR ANATOMY CONTRIBUTED TO THE EVENT. NO ADDITIONAL INFORMATION.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 18326204 ↗MalfunctionJan 10, 2023Packaging Problem; Packaging Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16132628 ↗InjurySep 7, 2021Unintended Movement; Unintended Movement
NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.
Patient problems: Bone Fracture(s); Muscle/Tendon Damage
MAUDE report 12432846 ↗InjuryJul 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT IS SCHEDULED FOR A RIGHT HIP REVISION APPROXIMATELY 12 YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. NO REVISION HAS BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information; No Information
MAUDE report 6746407 ↗
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- G7® Acetabular System 110010263Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive11 reports
- G7 CURVED INSERTER THREADED SHAFT 110003454Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive9 reports
- G7® Acetabular System 110010266Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive9 reports
- G7 OSSEOTI ACETABULAR SHELL 110010265Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive7 reports
- G7® 110010717Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive7 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.