G7® ACETABULAR LINER 010000985Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of G7 Acetabular Liner (85)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00880304989092), received between Feb 9, 2022 and Jul 14, 2025 — classified as 7 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).
3 other recalls cover devices cleared under the same FDA submission (K121874); they may or may not involve this specific model.
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
- Device Dislodged or Dislocated4
- Difficult to Insert3
- Adverse Event Without Identified Device or Use Problem2
- Detachment of Device or Device Component1
- Unstable1
Patient problems
- Joint Dislocation5
- No Clinical Signs, Symptoms or Conditions3
- Joint Laxity1
- Unspecified Infection1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryJul 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED PATIENT HAD PRIMARY HIP ARTHROPLASTY AND WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT WAS REVISED ONE (1) YEAR POST IMPLANTATION, AND THE HEAD AND LINER WERE EXPLANTED. THE PATIENT UNDERWENT AN ADDITIONAL REVISION SURGERY DUE TO DISLOCATION. THE LINER WAS EXPLANTED.
Patient problems: Joint Dislocation
MAUDE report 22495943 ↗InjuryJul 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 9 MONTHS AND 12 DAYS POST IMPLANTATION DUE TO A DISLOCATION. LOOKING AT THE LINER UPON REMOVAL IT WAS EVIDENT THERE WAS SOME DAMAGE THAT LOOKED TO BE FROM LEVERING. SURGEON WAS UNCERTAIN IF IT WAS A DEFICIENCY OR IF MAXIMUM LEVERAGE FORCE WAS ACHIEVED THAT ALLOWED THIS LINER TO BE DAMAGED/FOR THE HIP TO DISLOCATE AND BE REDUCED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 19766548 ↗InjuryDec 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 18345481 ↗InjuryDec 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 3 MONTHS POST IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 18317225 ↗MalfunctionJul 7, 2023Difficult to Insert; Difficult to Insert
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17283354 ↗InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT THA THAT WAS SUBSEQUENTLY REVISED APPROXIMATELY 6 WEEKS LATER DUE TO INFECTION. THE HEAD AND LINER WERE REVISED DURING THE WASHOUT SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 17190466 ↗MalfunctionMay 1, 2023Difficult to Insert; Difficult to Insert
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16844981 ↗InjuryFeb 7, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Joint Laxity
MAUDE report 16311647 ↗MalfunctionNov 21, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE LINER 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 15833021 ↗InjuryFeb 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SURGEON INTENDED TO CHANGE THE ANTEVERSION OF THE ARCOS PROXIMAL BODY DUE TO THE FREEDOM CONSTRAINED HEAD DISASSOCIATING FROM THE LINER. SUBSEQUENTLY, THE SURGEON WAS UNABLE TO DISLODGE THE ARCOS PROXIMAL BODY FROM THE DISTAL STEM. THEREFORE, HE REVISED THE FREEDOM LINER AND HEAD. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 13500184 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K121874. One submission often covers many models, so check the product and lot details in each record.
- Z-0007-2023 · Aug 25, 2022 · Open, ClassifiedG7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
- Z-1837-2014 · May 7, 2014 · TerminatedG7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
- Z-1838-2014 · May 7, 2014 · TerminatedG7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
Other Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented devices
- AcuMatch 142-32-27Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented2 recalls0 reports
- Novation 140-36-52Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall8 reports
- G7 DEPTH GAUGE 110010717Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented54 reports
- Novation 140-32-52Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall2 reports
- Novation 142-32-61Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall1 report
- Novation 140-36-54Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall1 report
- Novation 142-32-51Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall0 reports
- Novation 142-40-64Exactech, Inc. · Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall0 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.
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