G7® Acetabular System 110010263Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00887868356018), received between Jan 31, 2023 and May 20, 2026 — classified as 10 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Adverse Event Without Identified Device or Use Problem7
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Malposition of Device1
- Migration1
Patient problems
- Bone Fracture(s)3
- Bursitis3
- Pain2
- Aseptic loosening1
- Discomfort1
- Hematoma1
- Insufficient Information1
- Joint Dislocation1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2026Migration
IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO DUE TO INSTABILITY. PATIENT WAS TO BE NON-WEIGHT BEARING AND PUT WEIGHT ON THEIR LEG. A SCREW FRACTURED AND THE CUP SHIFTED AFTER. REVISED TO ANOTHER CUP OF THE SAME SIZE AND INCLUDED AN AUGMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Laxity
MAUDE report 25237244 ↗InjurySep 29, 2025Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY TWO MONTHS LATER DUE TO DISLOCATION AND CUP MALPOSITION. THE CUP WAS RETROVERTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 23166837 ↗InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED ONGOING TROCHANTERIC BURSITIS REQUIRING CORTISONE INJECTIONS AT 11, 16, AND 19 MONTHS POSTOP. NO COMPLICATIONS CONCERNING THE IMPLANTS HAVE BEEN IDENTIFIED ON X-RAY. FOLLOW-UPS TO GATHER ADDITIONAL INFORMATION ARE CURRENTLY IN PROCESS.
Patient problems: Bursitis; Pain
MAUDE report 22893050 ↗InjuryMay 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 2 DAYS POST IMPLANTATION DUE TO A PERI-PROSTHETIC FRACTURE FROM A FALL. THE X-RAY RESULTS ALSO SHOWED POSSIBLE LOOSENING OF THE ACETABULAR CUP. THE CUP REMAINS IMPLANTED. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT
Patient problems: Aseptic loosening
MAUDE report 22084460 ↗InjuryApr 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bursitis; Pain
MAUDE report 21784620 ↗InjuryFeb 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO UNKNOWN REASONS.THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 21332867 ↗MalfunctionJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: Bone Fracture(s); Osteopenia/ Osteoporosis
MAUDE report 21137650 ↗InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Bursitis; Discomfort
MAUDE report 20833342 ↗InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bone Fracture(s)
MAUDE report 20416702 ↗InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY FIVE DAYS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A FRACTURE. PATIENT HAD A PROXIMAL FEMUR REPLACEMENT AND PELVIC FIXATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s)
MAUDE report 20359295 ↗InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT HIP JOINT DEBRIDEMENT APPROXIMATELY TWO WEEKS POST IMPLANTATION DUE TO EXCESSIVE DRAINAGE AND HEMATOMA. SUBSEQUENTLY, FIVE WEEKS POST-OP, THE PATIENT EXPERIENCED DELAYED HEALING OF THE LEFT TOTAL HIP ARTHROPLASTY WOUND. THE SURGEON UTILIZED THE PREVIOUS INCISION AND PERFORMED AN ARTHROTOMY. THE INCISION WAS ENTIRELY INTACT EXCEPT FOR A PIN HOLE AT THE CENTRAL PORTION. ONCE THE PIN HOLE WAS DISSECTED, THE SURGEON ENCOUNTERED A FLUID COLLECTION IN THE SUBCUTANEOUS REGION WITH A SMALL AMOUNT OF FATTY NECROSIS AND THE PRESENCE OF SEROUS FLUID. THREE CULTURES WERE OBTAINED AND SENT TO PATHOLOGY. THE WOUND WAS IRRIGATED AND DEBRIDED, AND THERE WAS NO PURULENCE OR EVIDENCE OF FRANK INFECTION PRESENT. A FORMAL ARTHROTOMY WAS THEN PERFORMED TO ENSURE ADEQUATE IRRIGATION AND DEBRIDEMENT WITH INTACT IMPLANTS NOTED. THE SURGEON REPORTED THAT THE EVENT WAS PROBABLY RELATED TO PROCEDURE; NOT RELATED TO DEVICE AND OR INSTRUMENTS. THE PATIENT HAD BEEN RECEIVING ROCEPHIN BUT WAS SWITCHED TO IV DAPTOMYCIN DUE TO RASH FROM ROCEPHIN. APPROXIMATELY ONE WEEK POST ARTHROTOMY, THE PATIENT WAS EVALUATED AT THE ER FOR DYSPNEA, TACHYCARDIA AND LEFT LEG PAIN. A
Patient problems: Hematoma; Pulmonary Embolism; Unspecified Infection
MAUDE report 16272594 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.