G7 STRAIGHT MONOBLOCK ACETABULAR 110003450Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biomet G7 acetabular component is used in hip replacement. The 23 reports mostly describe threaded inserter and impactor parts breaking, deforming or cross-threading, making them hard to attach or remove, with no patient involvement mentioned. There are no deaths and no injuries. No recalls name this device.
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
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00880304532694), received between Jun 12, 2020 and May 27, 2026 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Fracture” (7 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture7
- Material Deformation5
- Separation Failure5
- Damaged Thread3
- Difficult to Remove3
- Degraded1
- Difficult to Insert1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Fracture
IT WAS REPORTED THAT THREADS FROM A STRAIGHT SHELL INSERTER BROKE OFF AND REMAINED WITHIN THE ACETABULAR CUP APEX HOLE DURING USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25303197 ↗MalfunctionSep 5, 2025Damaged Thread; Damaged Thread
IT WAS REPORTED THAT THE ACETABULAR SHELL INSERTER HANDLE DID NOT SECURELY ATTACH DUE TO THE THREADS. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22976205 ↗MalfunctionJun 26, 2025Damaged Thread; Damaged Thread
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22335333 ↗MalfunctionOct 9, 2024Difficult to Insert; Damaged Thread; Difficult to Insert; Damaged Thread
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20409170 ↗MalfunctionAug 14, 2024Material Deformation; Material Deformation
IT WAS REPORTED THE MODULAR HANDLE CROSS THREADED CAUSING THE SHELL TRIALS TO BE DIFFICULT TO REMOVE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19983743 ↗MalfunctionJul 5, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE LINER IMPACTOR THREADS WERE CROSS THREADED AND IT CAUSED G7 IMPACTORS TO BECOME DAMAGED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19679174 ↗MalfunctionMar 19, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18935040 ↗MalfunctionMar 8, 2024Material Deformation; Separation Problem; Material Deformation; Separation Problem
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18864989 ↗MalfunctionNov 29, 2023Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT WHEN THE SURGEON TRIED TO LOOSEN THE IMPACTOR FROM THE SHELL, IT WAS UNABLE TO BE REMOVED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18226517 ↗MalfunctionJul 13, 2023Fracture; Material Deformation; Fracture; Material Deformation
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17316862 ↗MalfunctionMar 30, 2023Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16645971 ↗MalfunctionNov 4, 2022Separation Failure; Material Deformation; Separation Failure; Material Deformation
IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE SURGEON SURGEON IMPACTED THE CUP BUT WAS NOT SATISFIED WITH THE POSITION SO THE IMPACTOR WAS ATTACHED AGAIN. AFTER SUCCESSFULLY REPOSITIONING THE CUP, THE SURGEON WAS NOT ABLE TO GET THE IMPACTOR HANDLE TO RELEASE FROM THE CUP. POTENTIALLY THE THREADS WERE DAMAGED. THE IMPACTOR WAS EVENTUALLY ABLE TO BE REMOVED FROM THE CUP WITHOUT FURTHER INCIDENT. THERE WAS NO 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 15729337 ↗MalfunctionAug 25, 2022Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY, THE CUP INSERTER WOULD NOT DISENGAGE FROM THE CUP. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15298039 ↗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 14756387 ↗MalfunctionMay 13, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY THE THREADS OF THE INSERTER FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION AND ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14397860 ↗MalfunctionMay 11, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY, THE THREADS OF THE INSERTER FRACTURED INTO THE CUP. THE SURGEON HAD TO REMOVE THE CUP FROM THE PATIENT'S BONE WITH ANOTHER INSERTER. WHILE DOING THIS, THE SECOND INSERTER'S THREADS STRIPPED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION AND ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14366112 ↗MalfunctionMar 23, 2022Fracture; Fracture
IT WAS REPORTED THAT THE INSTRUMENT FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13870376 ↗MalfunctionDec 9, 2021Separation Failure; Separation Failure
IT WAS REPORTED THAT THE G7 CUP WAS STUCK ON INSERTER HANDLE SO CUP WAS HARD TO SEAT WITH PRESS FIT. 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 12969619 ↗MalfunctionMay 19, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11847716 ↗MalfunctionApr 14, 2021Difficult to Remove; Difficult to Remove
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11667276 ↗MalfunctionApr 5, 2021Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11614479 ↗MalfunctionApr 5, 2021Material Deformation; Material Deformation
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11612546 ↗MalfunctionJun 12, 2020Degraded; Degraded
NO ADDITIONAL INFORMATION ON REPORTED EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10147839 ↗
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-1838-2014 · May 7, 2014 · TerminatedG7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
- Z-1837-2014 · May 7, 2014 · TerminatedG7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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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