G7® Acetabular System 010000660Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304524194), received between Mar 9, 2022 and Dec 1, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2025Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant; Insufficient Information; Pain

  MAUDE report 23682691 ↗
• 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 17558752 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, AT APPROXIMATELY EIGHT MONTHS POST-OP THE PATIENT DEVELOPED PERSISTENT LATERAL THIGH AND GROIN PAIN. TENDONITIS WAS SUSPECTED HOWEVER, THE SURGEON ALSO QUESTIONED IF THERE WAS AN ISSUE WITH THE PRESS-FIT FEMORAL COMPONENT. APPROXIMATELY 9 MONTHS POST-OP, AN INJECTION OF STEROIDS AND LOCAL ANESTHETIC WAS GIVEN UNDER FLUOROSCOPIC GUIDANCE. THE PATIENT HAS SINCE COMPLETED THE STUDY WITH IMPROVEMENT IN PAIN AND ALL IMPLANTS REMAINING IN PLACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Inflammation; Pain

  MAUDE report 17388225 ↗
• MalfunctionMar 9, 2022Positioning Failure; Positioning Failure

  NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Osteopenia/ Osteoporosis

  MAUDE report 13709253 ↗

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.