G7® Acetabular System 110010267Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00887868356056), received between Feb 1, 2022 and Jul 9, 2026 — classified as 11 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (6 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-Ingrowth6
- Adverse Event Without Identified Device or Use Problem2
- Migration2
- Device-Device Incompatibility1
- Difficult to Insert1
- Insufficient Device Problem Information1
- Mechanical Jam1
Patient problems
- Failure of Implant5
- Joint Dislocation2
- No Clinical Signs, Symptoms or Conditions2
- Aseptic loosening1
- Bacterial Infection1
- Bone Fracture(s)1
- Erosion1
- Insufficient Information1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2026Mechanical Jam
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. DURING THE PROCEDURE, ZB CUP, LINER AND HEAD WAS IMPLANTED WITH DEPUY PRODUCT. THE PATIENT UNDERWENT A REVISION APPROXIMATELY 3 WEEKS POST-IMPLANTATION DUE TO RECURRENT DISLOCATIONS AND IMPINGING POSTERIOR AND INFERIOR ON THE CUP. THE CUP WAS REVISED TO BE MORE CLOSED WITH LESS ANTEVERSION IN AN EFFORT TO ACCOUNT FOR THE IMPINGEMENT AND A NEW FREEDOM CONSTRUCT IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation; Joint Impingement
MAUDE report 25763303 ↗InjurySep 8, 2025Loosening 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 IS BEING CONSIDERED FOR A SECOND REVISION ON AN UNKNOWN DATE DUE TO INSUFFICIENT FIXATION OF THE CUP. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening
MAUDE report 22991052 ↗MalfunctionJul 18, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT TWO LINERS COULD NOT BE IMPLANTED INTO THE CUP DURING THE PROCEDURE. ANOTHER TYPE OF LINER WAS USED TO COMPLETE THE PROCEDURE. SURGERY WAS DELAYED ABOUT 120 MINUTES. 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 22542674 ↗InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED FOR UNKNOWN REASONS NEARLY TWO MONTHS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 20367974 ↗InjuryApr 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. THE PATIENT HAD A RIGHT HIP REVISION APPROXIMATELY ONE MONTH AGO DUE TO RECURRENT DISLOCATIONS. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY A WEEKS AGO DUE TO A PELVIC FRACTURE WHICH LED TO CUP LOOSENING. IT WAS REPORTED THAT THE PELVIC FRACTURE WAS THOUGHT TO HAVE OCCURRED IN THE PREVIOUS REVISION. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Bone Fracture(s)
MAUDE report 19097091 ↗InjuryNov 21, 2023Migration; Migration
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 18186734 ↗InjurySep 14, 2023Migration; Migration
IT WAS REPORTED THAT DURING A REVISION OF UNKNOWN DEVICES, THE DOCTOR NOTED THAT THE ACETABULUM WAS NOT PREPARED CORRECTLY; THEREFORE, INSERTED THE CUP WITH FIXATION OF FOUR SCREWS. DURING THE ATTEMPTS OF REDUCTION, ENCOUNTERED DIFFICULTY AND UPON DELIVERY OF FORCE, LED TO ROTATION OF THE PRESS-FIT FEMORAL STEM. A CURVED STEM WAS THEN PLACED AND AS ADDITIONAL REDUCTION ATTEMPTS WERE MADE, THE STEM ALSO ROTATED, LEADING TO THE STEM BEING CEMENTED. IN THE PROCESS OF TESTING THE HIP, ONE EVENT OF DISLOCATION OCCURRED; THEREFORE, ADDITIONAL REDUCTION MANEUVERS WERE REPEATED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS TRANSPORTED OUT OF THE OR. AFTER APPROXIMATELY 1 HOUR, THE PATIENT WAS RETURNED TO THE OR DUE TO DISLOCATION. THE LINER WAS REVISED TO A FREEDOM LINER AND WAS SUCCESSFULLY REDUCED WITHOUT DISLOCATION. SUBSEQUENTLY, DUE TO THE USE OF TENSILE FORCE, THE CUP DETACHED FROM THE ACETABULAR WALL AND THE PATIENT WAS HOSPITALIZED HIP PENDENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 17744752 ↗InjuryJan 18, 2023Adverse 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: Bacterial Infection
MAUDE report 16195424 ↗InjuryJan 12, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO BONE LOSS AND LOOSENING OF THE IMPLANT. THE SURGERY WAS COMPLETED USING A BIRCH-SCHNEIDER CAGE CONSTRUCT. NO DELAY REPORTED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16148339 ↗InjuryDec 1, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP ARTHROPLASTY. THE PATIENT WAS REVISED APPROXIMATELY 2 YEARS POST HIP RESURFACING DUE TO LOOSENING OF ACETABULAR CUP. NO ADDITIONAL INFORMATION.
Patient problems: Failure of Implant
MAUDE report 15894286 ↗InjuryNov 28, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP PROCEDURE APPROXIMATELY NINE MONTHS¿ POST IMPLANTATION DUE TO OSTEOLYSIS AND LOOSENING. DURING THE PROCEDURE, BONE LOSS WAS NOTED, THE SHELL WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Erosion; Osteolysis
MAUDE report 15870981 ↗MalfunctionNov 21, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE LINERS WOULD NOT SEAT IN THE OSSEOTI SHELL. A NEW SHELL WAS REQUIRED TO COMPLETE THE PROCEDURE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15833023 ↗InjuryFeb 1, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP ARTHROPLASTY. THE PATIENT WAS NON-COMPLIANT (DUE TO THE PATIENT NOT FOLLOWING RESTRICTIONS AT REHAB) AND THE CUP, AUGMENT BLOCK, AND SCREWS LOOSENED. THEREFORE, THE PATIENT WAS REVISED WITH A BIGGER CUP, BIGGER AUGMENT, AND SCREWS APPROXIMATELY 1-2 MONTHS LATER. SUBSEQUENTLY, THE PATIENT WAS NON-COMPLIANT AGAIN, THEREFORE WILL BE REVISED AGAIN IN THE NEAR FUTURE WITH A CUSTOM TRIFFLANGE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 13412594 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.