G7 Acetabular Liner 010000937Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of G7 Acetabular Liner (85)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 1
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00880304527126), received between Oct 5, 2021 and Jan 6, 2026 — classified as 1 death, 5 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert7
- Adverse Event Without Identified Device or Use Problem4
- Device Dislodged or Dislocated2
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Joint Dislocation2
- Pain2
- Bone Fracture(s)1
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- Loss of Range of Motion1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: Pain
MAUDE report 23979170 ↗MalfunctionDec 12, 2024Difficult to Insert; Difficult to Insert
IT WAS REPORTED DURING SURGERY THAT THE LINER WAS UNABLE TO BE SEATED INTO THE SHELL. THE SURGEON INDICATED THE INITIAL INSERTION WAS UNSUCCESSFUL DUE TO SOFT TISSUE BETWEEN THE LINER AND SHELL. THE HIGH WALL LINER AND SOFT TISSUE WAS REMOVED, AND THE SURGEON TRIED TO RE-INSERT THE LINER. THE LINER DID NOT FULLY SEAT SITTING PROUD APPROXIMATELY 1MM. THE SURGEON REMOVED THE LINER AND OPENED A NEW LINER AND INSERTED INTO THE SHELL SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20914239 ↗InjuryNov 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 20744364 ↗InjuryFeb 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST-IMPLANTATION, THE PATIENT WAS REVISED DUE TO A DISLOCATION. THE HEAD WAS EXCHANGED AND THE LINER REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 18790687 ↗MalfunctionNov 14, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT DURING THE PROCEDURE THE SURGEON WAS UNABLE TO ASSEMBLE WITH LINER WITH THE SHELL. ANOTHER LINER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NOT HARM OR HEALTH CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18129411 ↗DeathJun 21, 2023Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY TWO WEEKS POST THE INITIAL PROCEDURE BECAUSE A PROPER FIT WAS NOT ABLE TO BE OBTAIN BETWEEN THE LINER AND THE SHELL DURING THE INITIAL PROCEDURE. THERE WAS THIS DELAY BETWEEN THE TWO PROCEDURES DUE TO NEEDING TO OBTAIN COMPATIBLE BLOOD PRODUCTS FOR THE PATIENT. THE SURGERY ITSELF WAS ALSO PROLONGED DUE TO NUMEROUS COMPLICATIONS INCLUDING EXCESSIVE BLEEDING, INCORRECT COMPONENT POSITIONING, FEMUR FRACTURE, AND ADDITIONAL DIFFICULTY WITH IMPLANT PLACEMENT. ULTIMATELY, SATISFACTORY IMPLANTATION WAS ACHIEVED AND THE PROCEDURE CONCLUDED. HOWEVER, THE PATIENT IS REPORTED TO HAVE EXPIRED WITHIN 4 HOURS AFTER THE CONCLUSION OF THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: Bone Fracture(s); Hemorrhage/Blood Loss/Bleeding
MAUDE report 17169411 ↗MalfunctionJun 6, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT DURING A PROCEDURE, THE LINERS FAILED TO ASSEMBLE INTO THE CUP AFTER MULTIPLE ATTEMPTS WITH MULTIPLE PRODUCTS. BECAUSE OF THIS, THE SURGEON TERMINATED THE PROCEDURE, REMOVED THE PROSTHESIS AND CLOSED LEAVING THE HIP WITHOUT IMPLANTED COMPONENTS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 17073493 ↗MalfunctionDec 6, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT DURING A REPLACEMENT PROCEDURE THE LINER WOULD NOT SEAT PROPERLY. ANOTHER LINER WAS OPENED AND SEATED WITHOUT ANY ISSUES. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15923498 ↗MalfunctionApr 13, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED DURING AN INITIAL HIP PROCEDURE THE ACETABULAR LINER WOULD NOT FIT INTO ACETABULAR SHELL PROPERLY. LINER WAS IMPACTED INTO SHELL. THE SURGEON WENT TO DISLOCATE THE HIP TO PUT THE DEFINITIVE HEAD ONTO THE STEM AND THE ACETABULAR LINER CAME OUT OF THE SHELL. HE TRIED TO RESEAT THE LINER BUT IT WOULD NOT SIT INTO THE SHELL CORRECTLY. NEW LINER WAS USED. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14104417 ↗MalfunctionDec 20, 2021Difficult to Insert; Difficult to Insert
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13047576 ↗InjuryOct 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. NO INTERVENTION TO DATE FOR COMPLAINT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: Pain
MAUDE report 12610433 ↗InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A STUDY PATIENT IS UNABLE TO PERFORM CIRCULAR MOTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Loss of Range of Motion
MAUDE report 12576629 ↗
Other Hip, semi-constrained, cemented, metal/polymer + additive, cemented devices
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- G7 OSSEOTI ACETABULAR SHELL 110010243Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented10 reports
- G7® Vivacit-E® 30123204Zimmer, Inc. · Hip, semi-constrained, cemented, metal/polymer + additive, cemented8 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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