G7 ACETABULAR SCREW 010000999Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00880304527478), received between Aug 25, 2022 and Mar 4, 2026 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO INSTABILITY, RECURRENT DISLOCATIONS, AND IMPINGEMENT FROM POOR POSITIONING OF IMPLANTS. THE SURGEON ATTRIBUTED THE RECURRENT DISLOCATION TO POOR CUP PLACEMENT. THE TROCHANTERIC CLAW HAD ANTERIOR FIXATION RESULTING IN TISSUE IMPINGEMENT. DURING THE REVISION, A COMPETITOR CUP WAS CEMENTED INTO THE EXISTING CUP; THE HEAD AND LINER WERE EXCHANGED; AND THE STEM AND CLAW WERE RETAINED WITH SOME TISSUE AROUND THE GREATER TROCHANTER DEBRIDED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation; Joint Impingement; Joint Laxity; Pain

  MAUDE report 24511740 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s)

  MAUDE report 23554924 ↗
• InjuryMar 10, 2025Fracture; Off-Label Use; Fracture; Off-Label Use

  NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 21559369 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY SIX MONTHS POST IMPLANTATION DUE TO A PELVIC FRACTURE THAT WAS EXPERIENCED AFTER A FALL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 21123892 ↗
• InjuryDec 5, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY FOUR MONTHS POST IMPLANTATION DUE TO A DISSOCIATION AND PERI-PROSTHETIC FRACTURE. THE STEM, LINER, BEARING, AND HEAD WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 20852319 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY FIVE DAYS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A FRACTURE. PATIENT HAD A PROXIMAL FEMUR REPLACEMENT AND PELVIC FIXATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 20397687 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN EIGHTY-YEAR-OLD PATIENT WITH A SIGNIFICANT CARDIAC HISTORY HAD A RIGHT TOTAL HIP ARTHROPLASTY WITH COMPETITOR PRODUCT AND, UNDERWENT A REVISION DUE TO FEMORAL LOOSENING AND SIGNIFICANT BONE LOSS. DURING THE PROCEDURE THE PATIENT HAD A TOTAL BLOOD LOSS OF 600ML OF BLOOD LOSS AND RECEIVED TWO UNITS OF RBCS. THE ACETABULAR SYSTEM WAS RETAINED, AND THE STEM, HEAD, AND LINER WERE REVISED WITHOUT FURTHER COMPLICATION. THE PATIENT DISPLAYED WORSENING DYSARTHRIA AND A CODE STROKE WAS CALLED. A CT AND MRI WERE PERFORMED, AND A CEREBELLAR STROKE WAS CONFIRMED. THE PATIENT REMAINED NPO UNTIL A SWALLOW STUDY WAS PERFORMED. DURING THE SWALLOW STUDY, THE PATIENT EXPERIENCED AN EPISODE OF COUGHING AND BECAME UNRESPONSIVE AND WAS FOUND IN CARDIAC ARREST. THE PATIENT UNDERWENT THREE ROUNDS OF CPR AND INTUBATED AND ROSC WAS ACHIEVED. THE PATIENT WAS TRANSFERRED TO MICU AND, THE MRI DISPLAYED A SHOWER OF EMBOLIC STROKES. NEUROLOGY NOTED THAT THE PATIENT WAS OFF SEDATION, MAINTAINED VENTILATION, AND WAS ABLE TO FOLLOW COMMANDS. THE PATIENT WAS DIAGNOSED WITH ASPIRATION PNEUMONIA AND AFTER WEANING OFF THE VENTILATOR, THE PATIENT EXPIRED. ALL IMPLANTS REMAINED IN PLACE AND NO FURTHER

  Patient problems: Aspiration/Inhalation; Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Pneumonia; Stroke/CVA

  MAUDE report 19528604 ↗
• InjuryJun 6, 2024Fracture; Fracture

  IT WAS REPORTED THE SCREW HEAD SHEARED OFF WHILE INSERTING DURING SURGERY. THE THREADED PORTION OF THE SCREW IS SECURE IN THE BONE AND WAS NOT REMOVED. THERE IS NO ADDITIONAL SURGERY SCHEDULED TO REMOVE THE REMAINING SCREW COMPONENT. AN ADDITIONAL SCREW WAS USED TO COMPLETE THE PROCEDURE. NO REPORTED CONTRIBUTING CONDITIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 19477655 ↗
• InjuryMay 21, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19360168 ↗
• InjuryMay 21, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19360164 ↗
• InjuryMay 21, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19360143 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST-IMPLANTATION THE PATIENT WAS REVISED DUE TO A FRACTURED ACETABULUM. THE SURGEON STATED THAT ACETABULUM FRACTURE CAUSE IS UNKNOWN BUT MAY HAVE OCCURRED AT THE TIME OF IMPLANTATION AND WENT UNNOTICED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Unequal Limb Length

  MAUDE report 19331279 ↗
• 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 18865639 ↗
• InjuryDec 15, 2023Loosening 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 WAS REVISED APPROXIMATELY 10 MONTHS LATER DUE TO LOOSENING OF THE ACETABULAR COMPONENTS. THE PRIMARY X RAY REPORTEDLY SHOWED THAT THE CUP WAS NEVER SEATED PROPERLY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18334096 ↗
• MalfunctionJul 11, 2023Material Twisted/Bent; Material Twisted/Bent

  NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17297980 ↗
• 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 16195447 ↗
• InjuryNov 21, 2022Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT 10 MONTHS AFTER A LEFT TOTAL ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO GROIN PAIN, LOOSENING AND MIGRATION OF THE ACETABULAR CUP. THE HEAD, LINER, SHELL AND SCREWS WERE ALL PLACED WITHOUT COMPLICATION. THE STEM WAS STABLE AND REMAINED INTACT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 15832938 ↗
• InjuryAug 25, 2022Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 2.5 MONTHS POST IMPLANTATION DUE TO A TROCHANTERIC AVULSION FRACTURE AND LOSS OF FIXATION WITH VERTICAL MIGRATION OF THE ACETABULAR CUP. THE STEM REMAINED INTACT AND ALL OTHER COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 15296545 ↗
• InjuryAug 25, 2022Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 2.5 MONTHS POST IMPLANTATION DUE TO A TROCHANTERIC AVULSION FRACTURE AND LOSS OF FIXATION WITH VERTICAL MIGRATION OF THE ACETABULAR CUP. THE STEM REMAINED INTACT AND ALL OTHER COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 15296437 ↗

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, Classified
  G7 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 · Terminated
  G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
• Z-1837-2014 · May 7, 2014 · Terminated
  G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.