G7® Acetabular System 010000664Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00880304524231), received between Aug 3, 2020 and Jan 5, 2026 — classified as 10 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Separation Failure; Damaged Thread

  IT WAS REPORTED THAT THE SCREW CAP WAS ATTEMPTED TO BE REMOVED BEFORE IMPLANTING. THE SCREW CAP IN THE CUP IS STRIPPED. THE CUP WAS NOT USED. 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 23959729 ↗
• MalfunctionDec 29, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919061 ↗
• InjuryAug 14, 2025Material Erosion; Adverse Event Without Identified Device or Use Problem; Material Erosion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-IMPLANTATION, THE PATIENT IS EXPERIENCING MULTIPLE ISSUES: A METALLIC TASTE IN THE MOUTH AND HAS CORRESPONDING NICKEL ALLERGY; A RASH ON THEIR LEG; FEELINGS OF THEIR FEMUR SHIFTING; TWO ROUNDS OF ANTIBIOTIC TREATMENT AND IV ANTIBIOTICS FOR INFECTION; INABILITY TO WALK MUCH; TOES GO NUMB WHEN LAYING ON SIDE; HEART ATTACK LIKE SYMPTOMS; BACK PAIN; POTASSIUM AND MAGNESIUM INFUSIONS FOR UNKNOWN REASON MAKING THEM FEEL WORSE; ALLEGED METAL IN URINE THAT SURGEON THINKS IS A KIDNEY STONE; OTHER GREEN PARTICLES IN URINE SUSPECTED AS SUTURE PIECES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain; Unspecified Infection

  MAUDE report 22809631 ↗
• MalfunctionJan 6, 2025Separation Failure; Material Deformation; Separation Failure; Material Deformation

  IT WAS REPORTED THAT THE TECHNICIAN COULDN'T GET SCREW HOLE COVER OUT OF THE SHELL RESULTING IN IT BECOMING STRIPPED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080517 ↗
• MalfunctionDec 12, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE SURGERY, THE SURGEON WAS INSERTING THE SCREW AND METAL DEBRIS WAS OBSERVED. IT WAS UNCLEAR WHETHER THE DEBRIS WAS FROM THE SCREW OR THE CUP. THE CUP WAS USED HOWEVER A NEW SCREW OPENED. 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 20915539 ↗
• InjuryNov 21, 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; Bursitis; Pain

  MAUDE report 20744388 ↗
• InjuryMay 24, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE SURGERY, THE SURGEON WAS ATTEMPTING TO IMPACT THE LINER WITH THE CUP. WHILE ATTEMPTING TO IMPACT, THE PATIENTS ACETABULAR BOTTOM CRACKED. THE SURGEON WAS UNABLE TO SUCCESSFULLY FIXATE THE LINER AND CUP AND DECIDED TO CHANGE TO A LARGER CUP. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 19390352 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT RECEIVED A CORTISONE INJECTION APPROXIMATELY THREE MONTHS POST IMPLANTATION FOR LATERAL HIP PAIN AND TROCHANTERIC BURSITIS. THEN AGAIN ONE YEAR POST IMPLANTATION DUE TO MILD PAIN, MODERATE DIFFICULTIES WITH ADL¿S, SNAPPING SENSATION AND DIFFICULTY SLEEPING. THE PATIENT WAS PRESCRIBED A CORTICOSTEROID INJECTION IN THE RIGHT TROCHANTERIC BURSA, VOLTAREN GEL AND A PRESCRIPTION FOR PT, POSSIBLY DRY NEEDLING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bursitis; Pain; Swelling/ Edema

  MAUDE report 19222868 ↗
• MalfunctionMar 26, 2024Difficult 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 18977793 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 1.5 YEARS AGO. RIGHT AFTER SURGERY, THE PATIENT REPORTEDLY EXPERIENCED COGNITIVE DECLINE AND CONSTANT SYNCOPE WITH THE FEELING THAT SOMETHING FELT OFF AND WEIRD. SINCE SURGERY, THE PATIENT IS HAVING A CONSTANT BURNING PAIN, WARMTH TO THIGH, AND A HOT SPOT TO BURSA AREA. ADDITIONALLY, THE PATIENT IS EXPERIENCING DIFFICULTY WITH AMBULATION, AND WENT FROM A CANE TO A WALKER, AND NOW A WHEELCHAIR. THE PATIENT ALSO REPORTED INFLAMMATION IN THE BODY AND THE DEVELOPMENT OF DEGENERATIVE DISC DISEASE SINCE SURGERY. THE PATIENT HAS BEEN TREATED WITH PAIN MEDICATION AND NERVE ABLATION. IT WAS REPORTED THAT THE PATIENT WILL HAVE METAL ALLERGY TESTING COMPLETED IN THE NEAR FUTURE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Cognitive Changes; Hot Flashes/Flushes; Inflammation; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Swelling/ Edema; Syncope/Fainting

  MAUDE report 18721073 ↗
• MalfunctionDec 20, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18363245 ↗
• MalfunctionNov 29, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT A CUP HAD COLD WELDED SCREW CAPS AND THE SURGEON WAS UNABLE TO REMOVE THEM TO PLACE SCREWS. THE SURGERY WAS COMPLETED WITH A BACKUP CUP. 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 18226748 ↗
• 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 16645933 ↗
• InjuryOct 26, 2022Nonstandard Device

  PT UNDERWENT A TOTAL LEFT HIP ON (B)(6) 2022; A ZIMMER G7 SHELL ACETABULUM 3HX554MMF WAS USED; ZIMMER HAD A RECENT RECALL ON G7 SHELL IMPLANTS; PATIENT DEVELOPED A SURGICAL SITE INFECTION. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 15680442 ↗
• MalfunctionSep 19, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE LOCK ON THE IMPACTOR CROSS THREADED INTO THE CUP AND THE DRIVE BROKE WHILE TRYING TO DISENGAGE. THERE WERE NO HEALTH CONSEQUENCES OR IMPACT 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 15451173 ↗
• InjuryApr 20, 2022Loss of or Failure to Bond; Material Erosion; Loss of or Failure to Bond; Material Erosion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. THE PATIENT WAS REVISED APPROXIMATELY 5 YEARS POST IMPLANTATION DUE TO PAIN, ELEVATED METAL IONS AND COMPONENT MIGRATION. THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED AND A POLYETHYLENE LINER WAS IMPLANTED. SUBSEQUENTLY, THE PATIENT UNDERWENT A SECOND REVISION APPROXIMATELY 2 YEARS POST FIRST REVISION DUE TO PAIN, COMPONENT LOOSENING, FAILURE TO OSSEOINTEGRATE, AND METALLOSIS. THE SHELL, LINER, TAPER ADAPTER, AND HEAD WERE EXCHANGED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Inadequate Osseointegration; Metal Related Pathology; Pain; Synovitis

  MAUDE report 14164505 ↗
• InjuryApr 5, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THE PLASTIC BAG CONTAINING THE G7 SHELL WAS SEALED BUT THERE WAS AIR INSIDE. THE PLASTIC BAG OF THE G7 SHELL SHOULD BE VACUUMED AND SEALED, SO THE CLINICAL QUESTIONED THAT THE PROSTHESIS WAS FAULTY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14013908 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TOTAL HIP STUDY PATIENT UNDERWENT REVISION ON AN UNKNOWN DATE DUE TO PAINFUL PSOAS IMPINGEMENT CONFIRMED BY ULTRASOUND. NO ADDITIONAL INFORMATION.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 13470606 ↗
• InjuryOct 5, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Ambulation or Postural Difficulties; Pain; Unspecified Infection

  MAUDE report 12576723 ↗
• MalfunctionAug 3, 2020Difficult to Insert; Difficult to Insert

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10356433 ↗

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.