G7® Acetabular System 110017107Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304672147), received between May 6, 2021 and Jun 10, 2026 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT AN ACETABULAR CUP PACKAGING WAS OBSERVED WITH WHITE POWDER PRESENT. THERE WAS NO PATIENT IMPACT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460460 ↗
• DeathJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY TWO WEEKS POST THE INITIAL PROCEDURE BECAUSE A PROPER FIT WAS NOT ABLE TO BE OBTAIN BETWEEN THE LINER AND THE SHELL DURING THE INITIAL PROCEDURE. THERE WAS THIS DELAY BETWEEN THE TWO PROCEDURES DUE TO NEEDING TO OBTAIN COMPATIBLE BLOOD PRODUCTS FOR THE PATIENT. THE SURGERY ITSELF WAS ALSO PROLONGED DUE TO NUMEROUS COMPLICATIONS INCLUDING EXCESSIVE BLEEDING, INCORRECT COMPONENT POSITIONING, FEMUR FRACTURE, AND ADDITIONAL DIFFICULTY WITH IMPLANT PLACEMENT. ULTIMATELY, SATISFACTORY IMPLANTATION WAS ACHIEVED AND THE PROCEDURE CONCLUDED. HOWEVER, THE PATIENT IS REPORTED TO HAVE EXPIRED WITHIN 4 HOURS AFTER THE CONCLUSION OF THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17408670 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE REAMING TO APPROPRIATE SIZE, IMPACTION OF THE CUP RESULTED IN CUP DEFORMING THE ACETABULAR BONE. SURGEON ELECTED TO UPSIZE WITH A NEW, LARGER CUP. ORIGINAL CUP WITH LINER WERE WASTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 11783425 ↗