G7® Acetabular System 010000661Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00880304524200), received between Aug 3, 2021 and Feb 22, 2026 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY, THE SURGEON HAD DIFFICULTY DRIVING THE SCREW INTO THE ACETABULAR CUP HOLE. SWITCHING TO AUTOMATED, BATTERY POWERED IMPACTION TO STRIKE THE SCREWDRIVER CAUSED THE SCREW TO GO PAST THE CUP'S SCREW HOLE. THERE ARE NO PLANS TO REMOVE THE SCREWS. 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 24410565 ↗
• MalfunctionJan 13, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE SCREW HOLE COVERS WILL NOT COME OUT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139375 ↗
• InjuryDec 30, 2024Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE APPROPRIATE IMPLANT WAS SELECTED FOR THE PATIENT. SUBSEQUENT TO IMPLANTATION, THE PATIENT EXPERIENCED A PERIPROSTHETIC FRACTURE IN THE ACETABULUM. IT IS NOT KNOWN WHAT CAUSED THE FRACTURE. THE PATIENT WAS REVISED AND A LARGER IMPLANT USED AS A RESULT OF THE FRACTURE THAT HAD OCCURRED FOR BETTER FIXATION. THE PATIENT IS REPORTED TO BE DOING WELL AFTER THE REVISION SURGERY. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 21037166 ↗
• InjuryMar 26, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT A PATIENT UNDERWENT A LEFT HIP PROCEDURE. APPROXIMATELY, NINE DAYS POST IMPLANTATION FOR PAIN AND INSTABILITY. ALL OF THE ITEMS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Osteopenia/ Osteoporosis; Pain

  MAUDE report 18977318 ↗
• MalfunctionMar 11, 2024Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED. ALTHOUGH IT WAS INITIALLY REPORTED THAT A LARGER CUP AND LINER WERE IMPLANTED, IT WAS SINCE DETERMINED THAT THE LARGER CUP AND LINER WERE NOT ACTUALLY USED. INSTEAD, THE CUP AND LINER THAT WOULD NOT LOCK WERE SOAKED IN COLD WATER FOR 10-MINUTES, AND THEN THE PRODUCTS WERE SUCCESSFULLY IMPLANTED. THERE WAS NOT A 35-MINUTE DELAY AS INITIALLY REPORTED, THERE WAS ACTUALLY A 15-MINUTE DELAY DUE TO THE SOAK. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18877494 ↗
• MalfunctionNov 6, 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 18072972 ↗
• InjurySep 11, 2023Positioning Failure; Positioning Failure

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719905 ↗
• InjuryAug 16, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED ON THAT DURING A PROCEDURE, AN UNKNOWN EVENT CAUSING LEFT FEMORAL FRACTURE IN A PATIENT WITH HISTORY OF PREVIOUS LEFT FEMORAL NECK FRACTURE AND MODERATE ANEMIA WITH NO REPORT OF PREVIOUS THA. DURING THE SURGERY ENCOUNTERED EBL 1500 ML DUE TO PATIENTS LEFT INTER-ROTOR FRACTURE COMBINED WITH THE OLD FRACTURE OF NECK OF FEMUR, AND THE LOCAL SOFT TISSUE EDEMA AND ADHESION, THAT CAUSED A LOT OF BLEEDING DURING THE OPERATION. PATIENT WAS TRANSFUSED WITH 9 UNITS OF RBC AND 950 ML OF FFP DURING THE EXTENDED SURGICAL REPAIR OF FRACTURE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s); Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17558722 ↗
• MalfunctionApr 20, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CUP COULD NOT BE REMOVED FROM THE IMPLANT TOOL. THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IN AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16778943 ↗
• MalfunctionJan 19, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON FOLLOWED SURGICAL TECHNIQUE AND GRINDED THE ACETABULUM, USED THE 47 TRIAL IMPLANT, THEN IMPLANTED THE ACETABULAR PROSTHESIS 48, WHICH WAS VERY STABLE. THE CORRESPONDING E1 LINER C-32 WAS THEN DISMANTLED, THE INSIDE OF THE ACETABULUM WAS CLEANED, AND THE LINER IMPLANTED. IT WAS FOUND THAT AFTER KNOCKING DOWN, THE LINER WAS STILL IN AN UNSTABLE STATE. REPEATED ATTEMPTS WERE MADE TO IMPLANT SEVERAL TIMES, BUT WAS STILL NOT STABLE, SO THE ACETABULAR PROSTHESIS WAS REMOVED. THERE WERE NO ADDITIONAL LINERS OF THIS SIZE AVAILABLE AT THE FACILITY, AND THE SURGERY COULD NOT WAIT FOR THE SAME SIZE OF IMPLANT TO BE DELIVERED. SINCE THE INITIAL LINER COULD NOT BE DRIVEN INTO THE ACETABULAR CUP, AND THERE WERE NO OTHER ALTERNATIVE LINERS OF THE SAME SIZE AVAILABLE, THE PATIENT'S ACETABULUM WAS CONTINUED TO BE GROUND, AND A LARGER ACETABULAR CUP AND LINER WERE USED. THE ACETABULAR FILE WAS INCREASED BY ONE, AND THE 50TH ACETABULAR CUP WAS IMPLANTED, ALONG WITH THE CORRESPONDING E1 LINER, WHICH WAS VERY STABLE AFTER IMPLANTATION. THE SURGERY WAS PROLONGED BY 30 MINUTES. THE PATIENT HAD NO OTHER PROBLEMS AT THIS TIME, AND THERE WERE NO CONTRIBUTING PATIENT C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16205607 ↗
• 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 15298074 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 8 MONTHS INITIAL RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT DEVELOPED IT BAND SYNDROME AND REQUIRED PHYSICAL THERAPY. SYMPTOMS RESOLVED APPROXIMATELY 5 MONTHS LATER. ALL COMPONENT REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 15151745 ↗
• MalfunctionAug 3, 2021Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12265959 ↗

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.