G7® Acetabular System 110010244Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of G7 Acetabular System (42)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Biomet G7 hip implant replaces the socket part of the hip joint. The 23 reports mostly describe parts breaking during surgery, pieces not fitting together or separating afterward, and implants loosening or shifting, sometimes needing repeat surgery. There were no deaths and 11 injuries mentioned. No recalls name this device, and reports fell to 2 in the last 12 months from 11 the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00887868355882), received between Aug 19, 2021 and Aug 19, 2026 — classified as 12 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Fracture3
- Positioning Failure3
- Separation Failure3
- Loosening of Implant Not Related to Bone-Ingrowth2
- Migration2
- Damaged Thread1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Failure of Implant3
- Hematoma2
- Insufficient Information2
- Unspecified Infection2
- Bone Fracture(s)1
- Impaired Healing1
- Joint Dislocation1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient underwent a hip revision approximately two months post implantation due to infection. During the procedure, it was noted that the G7 52 E Cup was revised. Due diligence is in progress for this complaint; to date no additional information or product has been received.
Patient problems: Unspecified Infection
MAUDE report 50327446 ↗MalfunctionJan 13, 2026Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION IS AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24052627 ↗InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED FROM A CLINICAL STUDY THAT A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, IT HAS BEEN REPORTED THAT THE PATIENT DEVELOPED ERYTHEMA, SWELLING AND DISCOLORATION AND DIAGNOSED WITH RESOLVING HEMATOMA
Patient problems: Hematoma
MAUDE report 23828995 ↗InjuryOct 17, 2025Adverse 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: Hematoma
MAUDE report 23323886 ↗InjuryOct 16, 2025Fracture; Fracture
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THIS REPORT IS A DUPLICATE OF (B)(4). THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. IF ADDITIONAL INFORMATION IS TO BE RECEIVED CONCERNING THE REPORTED EVENT, A SUPPLEMENTAL MDR WILL BE SUBMITTED UNDER (B)(4).
Patient problems: Joint Dislocation
MAUDE report 23309579 ↗MalfunctionSep 8, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT WHILE INSERTING THE SCREWS INTO THE CUP, ONE OF THE SCREWS FRACTURED AND THE OTHER SCREW WENT THROUGH THE HOLE OF THE CUP. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THE SURGEON NOTED THAT THE PATIENT HAD HARD BONE. 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 22991187 ↗MalfunctionJun 17, 2025Separation Failure; Damaged Thread; Separation Failure; Damaged Thread
IT WAS REPORTED THAT THE SHELL AND MANHOLE COVER (COVER THAT COMES OFF IN ORDER TO PLACE SCREWS) WOULD NOT SEPARATE. AFTER ATTEMPTS TO DISENGAGE THEM, THE MANHOLE COVER WAS STRIPPED, AND THE SHELL BECAME UNUSABLE. ANOTHER SHELL WAS USED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22236194 ↗InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED DURING SURGERY, THE G7 OSSEOTI CUP AND METAL LINER DELIVERED WERE USED, AND POST-SURGERY X-RAYS CONFIRMED THAT THE METAL LINER WAS SEPARATED FROM THE CUP. THE PATIENT WAS REVISED, AND ANOTHER METAL LINER WAS USED, ALLOWING FOR A SUCCESSFUL REOPERATION WITHOUT ISSUES.
Patient problems: Insufficient Information
MAUDE report 22178563 ↗MalfunctionJun 3, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DURING AN INITIAL SURGERY, THE POLE LOCKING SCREW WAS TOO SMALL FOR THE INTENDED OPENING AND IT WOULD FALL THROUGH. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT HARM. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22133289 ↗MalfunctionApr 30, 2025Material Deformation; Material Deformation
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21937981 ↗InjuryMar 5, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 1 YEAR AND 6 MONTHS POST IMPLANTATION DUE TO CUP MALPOSITIONING AND THE ACETABULAR SCREW BREAKING THROUGH THE CUP. THE ACETABULAR CUP WAS REMOVED AND REPLACED. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21526223 ↗MalfunctionJan 6, 2025Fracture; Fracture
IT WAS REPORTED IN A WORN INSTRUMENT REPORT THAT THERE WAS DAMAGE TO THE IMPLANT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21080128 ↗MalfunctionNov 15, 2024Device-Device Incompatibility; Device-Device Incompatibility
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20693584 ↗InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20388015 ↗InjuryMar 8, 2024Positioning Problem; Positioning Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP ARTHROPLASTY ON AN UNKNOWN DATE AND IS BEING CONSIDERED FOR A REVISION IN APPROXIMATELY ONE MONTH. IT WAS REPORTED THAT THE ORIGINAL SURGEON REAMED OUT THE POSTERIOR WALL OF THE ACETABULUM, THE CUP WAS THEN IMPLANTED WITH NO POSTERIOR SUPPORT, AND A VOID WAS LEFT BETWEEN THE IMPLANT AND ANTERIOR BONE. THERE WAS NO ISSUE WITH THE IMPLANT. NO ADDITIONAL INFORMATION.
Patient problems: Insufficient Information
MAUDE report 18865616 ↗MalfunctionDec 29, 2023Fracture; Fracture
IT WAS REPORTED THAT THE SURGEON OPENED THE IMPLANT AND ATTACHED THE CUP TO THE OFFSET INSERTER HANDLE. AS THE SURGEON IMPACTED THE CUP INTO THE ACETABULUM, THE RIM OF THE CUP BROKE OFF. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18419555 ↗MalfunctionDec 18, 2023Separation Failure; Separation Failure
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18344732 ↗MalfunctionOct 6, 2023Difficult to Insert; Difficult to Insert
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17885592 ↗InjuryJun 21, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT HIP PROCEDURE THAT WAS SUBSEQUENTLY REVISED APPROXIMATELY 12 DAYS LATER DUE TO AN ACETABULAR FRACTURE. IT WAS NOTED IN X-RAYS THAT THE ACETABULAR COMPONENT HAD LOOSENED, AND OSTEOPENIA WAS PRESENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s); Osteopenia/ Osteoporosis
MAUDE report 17169588 ↗MalfunctionMay 24, 2023Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE SCREW HOLE ON THE G7 52MM SHELL LIMITED HOLE WAS SPINNING AND WOULD NOT COME OFF. THE PRODUCT WAS NOT USED AND WAS REPLACED WITH A NEW ONE. THERE WAS A DELAY OF APPROXIMATELY 15 MINUTES. THERE WAS NO PATIENT HARM OR IMPACT. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16994960 ↗InjuryJan 12, 2023Positioning Failure; Migration; Positioning Failure; Migration
IT WAS REPORTED THAT DURING AN INITIAL HIP PROCEDURE, THE SURGEON OBSERVED THE CUP WAS POTENTIALLY NOT STABLE AND WAS CONFIRMED ON POST OPERATIVE X-RAY. THE SURGEON COMMENTED THAT THERE WAS POSSIBLY EXCESSIVELY REAMED THROUGH THE ACETABULAR FLOOR. THROUGH POST-OPERATIVE MONITORING, IT WAS OBSERVED THAT THE CUP HAD MIGRATED SUPERIORLY AND THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 16 DAYS LATER. DURING THE PROCEDURE, ALL COMPONENTS WERE REMOVED AND REPLACED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 16146553 ↗MalfunctionJun 21, 2022Separation Failure; Separation Failure
IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE SHELL INSERTER COULD NOT BE DISENGAGED FROM THE SHELL. ATTEMPTS TO UNSCREW THE HANDLE LED TO THE IMPLANT SPINNING AND LOSS OF PRIMARY FIXATION. THE SHELL WAS REMOVED FROM THE PATIENT AND A NEW SHELL AND INSERTER WERE USED TO COMPLETE THE SURGERY. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14756421 ↗InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Impaired Healing
MAUDE report 12342268 ↗
Other prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive devices
- G7® Acetabular System 010000665Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive31 reports
- G7® 110003450Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive29 reports
- 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® 110010717Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive7 reports
- G7 OSSEOTI ACETABULAR SHELL 110010265Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive7 reports
- G7 Acetabular Liner 010000927Biomet Orthopedics, LLC · prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive6 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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