G7® Acetabular System 010000663Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00880304524224), received between Jan 20, 2020 and Sep 24, 2026 — classified as 11 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 25, 2022Open, Classified

   The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention.

   Z-0007-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Loosening of Implant Not Related to Bone-Ingrowth

  It was reported that during an initial hip replacement procedure, a size 51 acetabular cup was trialed for fit. Initial stability was confirmed, and the surgical team was instructed to use a size 52 acetabular prosthesis. Following implantation, the acetabular cup was also reported to be stable. After securing the cup, the ceramic liner was opened and inserted. The edges were leveled, and an impactor was used to seat the liner. However, the ceramic liner fractured during impaction.Following the ceramic liner fracture, it was discovered that the previously stable acetabular cup had become slightly loose. The surgeon immediately thoroughly irrigated the acetabulum with water and removed the entire prosthesis. After adjusting the cup angle, a new size 52 acetabular cup was implanted and secured with two screws. The replacement cup was reported to be very stable. The liner was then opened and implanted, and the procedure was completed successfully. No additional information available for the reported event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882045 ↗
• MalfunctionNov 18, 2025Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGICAL TEAM REAMED THE CUP TO A SIZE 51 AND TRIALED A SIZE 51 WITHOUT ISSUE. AFTER OPENING A SIZE 52 CUP INTENDED FOR USE IN THE CASE, THE CUP WOULD NOT SEAT. THE TEAM ATTEMPTED TO SEAT THE CUP BY IMPACTING WITH A HAMMER AND WITHOUT, AND DURING LINER INSERTION A SCREW CAP WAS OBSERVED FLOATING INSIDE THE CUP. THE EVENT OCCURRED INTRAOPERATIVELY; NO ENVIRONMENTAL CONDITIONS WERE REPORTED. THERE IS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583084 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING RIGHT HIP ISSUES AND PAIN SINCE HIS INITIAL IMPLANTATION. IT IS NOW APPROXIMATELY 11 (ELEVEN) YEARS POST-SURGERY. AN MRI WAS PERFORMED THAT DISPLAYED SMALL CHRONIC BONE FRAGMENTS AT THE GREATER TROCHANTER; OTHERWISE, UNREMARKABLE WITHOUT EVIDENCE OF OSSEOUS ABNORMALITY OR OSTEOLYSIS. ALL PRODUCTS REMAIN IMPLANTED. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 23485636 ↗
• MalfunctionNov 3, 2025Separation 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 23452656 ↗
• MalfunctionSep 23, 2025Device-Device Incompatibility; Positioning Problem; Device-Device Incompatibility; Positioning Problem

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

  Patient problems: Bone Fracture(s)

  MAUDE report 23125014 ↗
• InjurySep 8, 2025Adverse 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: Insufficient Information

  MAUDE report 22991161 ↗
• MalfunctionAug 11, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SURGEON HAD ISSUES GETTING THE LINER AND CUP TO MATE. THE SURGEON WAS EVENTUALLY ABLE TO MATE THE DEVICES, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22778769 ↗
• MalfunctionMar 26, 2025Device-Device Incompatibility; Positioning Problem; Device-Device Incompatibility; Positioning Problem

  IT WAS REPORTED THAT DURING SURGERY, THE CERAMIC LINER COULD NOT BE FULLY IMPLANTED INTO THE CUP AFTER MULTIPLE ATTEMPTS, WHICH RESULTED IN LOOSENING OF THE CUP. THE SURGEON SUSPECTED THAT THE CUP DID NOT MATCH THE LINER. A NEW LINER AND CUP WERE USED TO COMPLETE THE PROCEDURE WITH A 20 MINUTE DELAY. 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 21696195 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN, SWELLING, BURNING SENSATION AND HAS A NICKEL ALLERGY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Burning Sensation; Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema

  MAUDE report 21228381 ↗
• MalfunctionJun 25, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED DURING A HIP ARTHROPLASTY THAT THE LINER NEVER INSERTED INTO THE CUP AFTER BEING HIT MULTIPLE TIMES. THE LINER NEVER CAUGHT OR EMBEDDED WITH THE G7 ACETABULAR CUP. THE LINER AND THE CUP WERE NOT IMPLANTED INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19608861 ↗
• InjuryJun 25, 2024Adverse 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: Ambulation or Postural Difficulties; Pain

  MAUDE report 19606917 ↗
• MalfunctionJun 7, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN INITIAL HIP PROCEDURE, THE POLYETHYLENE LINER WAS UNABLE TO BE IMPLANTED INTO THE CUP. REPEATED ATTEMPTS TO IMPLANT THE LINER AT THE CORRECT ANGLE CONTINUED TO FAIL. THE CORRESPONDING CERAMIC LINER WAS THEN USED AND COULD NOT BE IMPLANTED. THE FIRST CUP WAS REMOVED AND A SECOND, LARGER CUP WAS INSTALLED. THE SURGEON ATTEMPTED TO IMPLANT THE POLYETHYLENE LINER AND WAS UNSUCCESSFUL. THE CORRESPONDING CERAMIC LINER WAS ABLE TO BE SUCCESSFULLY IMPLANTED INTO THE SECOND CUP TO COMPLETE THE PROCEDURE. THERE WAS A 25 MINUTE SURGICAL DELAY. 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 19483130 ↗
• MalfunctionMar 25, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE CUP COULD NOT BE REMOVED FROM THE INSERTER DURING SURGERY. A DIFFERENT CUP AND INSERTER WERE USED TO COMPLETE THE PROCEDURE. THE CUP AND INSERTER WERE LATER SEPARATED. THERE WAS A 15 MINUTE DELAY. 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 18970160 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Impaired Healing

  MAUDE report 18901529 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A CLINICAL STUDY THAT AT THE ONE-YEAR POST-OP APPOINTMENT, THE PATIENT WAS EXPERIENCING MODERATE PAIN, DIFFICULTY WITH AMBULATION AND DAILY ACTIVITIES. SUBSIDENCE OF THE STEM WAS NOTED AS WELL. THEN, THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO PAIN, DIFFICULTY WITH AMBULATION AND DAILY ACTIVITIES. THE PATIENT WAS REMOVED FROM THE STUDY AND A REVISION OF ALL THE COMPONENTS WAS COMPLETED WITHOUT ANY KNOWN COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 18758158 ↗
• MalfunctionDec 8, 2023Difficult to Remove; Separation Failure; Difficult to Remove; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290160 ↗
• InjuryNov 29, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT WHILE INSERTING THE SCREW THROUGH THE CUP, THE SCREW PROCEEDED THROUGH THE SCREW HOLE IN THE CUP AND INTO THE ACETABULUM. UNSURE IF THE SCREW HEAD IS TOO SMALL OR THE SCREW HOLE IS TOO BIG AS THE SCREW IS UNABLE TO BE RETRIEVED FOR INSPECTION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18231686 ↗
• 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 18226518 ↗
• MalfunctionNov 7, 2023Difficult to Insert; Difficult to Insert

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18083577 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 17009730 ↗
• MalfunctionApr 24, 2023Packaging Problem; Packaging Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16794954 ↗
• MalfunctionApr 4, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LINER COULD NOT ASSEMBLE THE CUP. THE SURGERY WAS COMPLETED USING A BIGGER CUP AND CORRESPONDING LINER. THERE WAS A 31 MINUTE DELAY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16672677 ↗
• MalfunctionJan 30, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE THREADED SHAFT IS COMING LOOSE FROM THE CUP. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16265262 ↗
• MalfunctionOct 3, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE STERILE PACKAGING OF A DEVICE WAS BEING QUESTIONED FOR POSSIBLE STERILITY ISSUE. THE IMPLANT WAS ULTIMATELY USED WITHOUT CONFIRMING IF THE STERILITY HAD BEEN BREACHED. 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 15529357 ↗
• MalfunctionJul 13, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHEN THE PATIENT UNDERWENT HIP SURGERY, AN ACETABULAR PROSTHESIS WAS IMPLANTED. WHEN THE CERAMIC-LINED PROSTHESIS WAS READY TO BE IMPLANTED, THE SCREW IN THE CUP COULD NOT BE REMOVED UNDER NORMAL OPERATION AND THE CERAMIC LINING COULD NOT BE IMPLANTED PROPERLY, SO THE SURGERY HAD TO BE COMPLETED BY REPLACING THE CUP TO A LARGER PROSTHESIS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15000918 ↗

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-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.