G7® Acetabular System 010000665Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00880304524248), received between Sep 10, 2019 and Sep 30, 2026 — classified as 16 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Positioning Problem

  It was reported that during the surgery the 56 mm cup could not be fully seated. The surgical team proceeded with an alternative approach and reamed to a different size. 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 50945273 ↗
• InjuryAug 14, 2025Material Erosion; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Material Erosion; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Erythema; Hemorrhage/Blood Loss/Bleeding; Inflammation; Insufficient Information; Metal Related Pathology; Necrosis; Pain; Subluxation; Swelling/ Edema

  MAUDE report 22805021 ↗
• InjuryJul 25, 2025Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  IT WAS REPORTED A PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY THE PATIENT FELT A SHARP PAIN AND A POP FOR A COUPLE OF DAYS AND THEN IT WENT AWAY. PATIENT SCHEDULED AN APPOINTMENT, AND THE CLINIC TOOK AN X-RAY WHERE IT WAS DETERMINED THE DUAL MOBILITY LINER HAD DISSOCIATED. SUBSEQUENTLY, A REVISION OCCURRED ON APPROXIMATELY ONE AND A HALF MONTHS AFTER INITIAL IMPLANTATION DUE TO THE DUAL MOBILITY LINER DISASSOCIATED FROM THE CUP. THE CUP AND STEM WERE RETAINED, WHILE THE DUAL MOBILITY COMPONENTS WERE REVISED.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 22607760 ↗
• MalfunctionJun 19, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW CAP WAS UNABLE TO BE REMOVED FROM THE 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 22289159 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, AFTER THE FIRST YEAR, DEVELOPED CONTRALATERAL LEG SHORTENING AND BEGAN EXPERIENCING PAIN, A LIMP, AND PROBLEMS WALKING. THE PATIENT WAS PRESCRIBED PHYSICAL THERAPY, AND THE OUTCOME IS PENDING.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 21917617 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 10 YEARS POST IMPLANTATION, THE PATIENT EXPERIENCED LEFT LATERAL PAIN CONSISTENT WITH TROCHANTER BURSITIS. PATIENT TOOK OVER THE COUNTER MEDICATION (NSAIDS) AND OUT PATIENT THERAPY WERE ADMINISTERED AND THE IMPLANTS REMAIN IMPLANTED. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bursitis; Pain

  MAUDE report 21737987 ↗
• MalfunctionJan 27, 2025Material Deformation; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21242547 ↗
• MalfunctionJan 7, 2025Separation Failure; Separation Failure

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21096154 ↗
• MalfunctionNov 21, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ONE HUB CAP ON THE INSIDE OF THE SHELL WAS PREVIOUSLY STRIPPED BEFORE THE SHELL WAS OPENED FOR USE. THE TECH AND SURGEON WERE UNABLE TO REMOVE THE HUB CAP TO PLACE A SCREW. ANOTHER SHELL WAS OPENED TO PLACE A SCREW AND COMPLETE THE PROCEDURE. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20744299 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 2 YEARS POST IMPLANTATION OF A LEFT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO AN UNKNOWN REASON. THE STEM WAS RETAINED, AND THE OTHER PRODUCTS WERE SCRAPPED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20146989 ↗
• InjuryMar 11, 2024Adverse 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: Bursitis; Pain

  MAUDE report 18876646 ↗
• MalfunctionFeb 5, 2024Difficult to Remove; Difficult to Remove

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640470 ↗
• MalfunctionAug 17, 2023Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE NURSE COULD NOT UNSCREW THE MIDDLE SCREW PLUG IN THE CUP. THEREFORE, THE CUP WAS NOT IMPLANTED IN THE PATIENT AND ANOTHER CUP OF THE SAME SIZE WAS USED TO COMPLETE THE CASE. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569050 ↗
• 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 17558663 ↗
• MalfunctionJun 12, 2023Difficult to Remove; Difficult to Remove

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107375 ↗
• MalfunctionMay 17, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16948183 ↗
• InjuryFeb 13, 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)

  MAUDE report 16362491 ↗
• InjuryDec 30, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 18 MONTHS POST IMPLANTATION DUE TO IMPLANTS BEING WORN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 16078682 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION AND INSTABILITY OF THE IMPLANTS. DURING THE REVISION IT WAS NOTED THAT THERE WAS EXTENSIVE SCAR TISSUE THROUGHOUT THE JOINT, TISSUE DAMAGE TO POSTERIOR CAPSULE AND HETEROTOPIC BONE TO FEMUR AND ACETABULUM. THE HEAD AND LINER WERE EXCHANGED WITHOUT COMPLICATION. NOTED CONTRIBUTING FACTOR WITH HISTORY OF DIFFUSE IDIOPATHIC SKELETAL HYPEROSTOSIS WHICH PUTS MORE STRESS ON HIP WHEN BENDING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Extraskeletal ossification; Muscle/Tendon Damage; Pain; Scar Tissue

  MAUDE report 15934579 ↗
• InjuryNov 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  HOLD FOR TG IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 5 MONTHS POST IMPLANTATION DUE TO THE LINER DISSOCIATING FROM THE SHELL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 15827258 ↗
• MalfunctionSep 12, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THE G7 CUP THREAD WAS DAMAGED, THEREFORE THE INSERTER WAS UNABLE TO BE REMOVED DURING THE SURGERY AFTER IMPLANTED. ANOTHER CUP WAS USED. THERE WAS A TWENTY (20) MINUTE DELAY. 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 AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401332 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY PATIENT IS EXPERIENCING PAIN APPROXIMATELY 9 MONTHS LATER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 15295715 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING LEFT HIP PAIN APPROXIMATELY SEVEN (7) YEARS POST IMPLANTATION. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 15138534 ↗
• MalfunctionJul 22, 2022Degraded; Degraded

  IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY, THE SCREW COVERS WERE STRIPPED AND COULDN'T BE REMOVED FROM THE CUP. ANOTHER CUP WAS USED TO COMPLETE THE PROCEDURE. 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 15083384 ↗
• MalfunctionAug 24, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY, THE G7 CUP'S SUPERIOR SCREW HOLE COVER WOULD NOT UNSCREW. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. AN ADDITIONAL CUP WAS USED TO COMPLETE THE PROCEDURE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12359062 ↗

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-1837-2014 · May 7, 2014 · Terminated
  G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
• Z-1838-2014 · May 7, 2014 · Terminated
  G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.