G7® Acetabular System 010000667Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304524262), received between May 16, 2022 and May 20, 2024 — classified as 1 injury, 2 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

2 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.

Recalls naming this device

1. Aug 25, 2022Open, Classified

   The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention.

   Z-0007-2023 · Root cause: Under Investigation by firm · FDA record ↗

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.

• InjuryMay 20, 2024Material Erosion; Material Erosion

  IT WAS REPORTED THAT AFTER IMPLANTATION, THE PATIENT HAD ONGOING PAIN. PATIENT STARTED HAVING SWOLLEN LYMPH NODES AND HIGH WHITE BLOOD CELL COUNT MORE RECENTLY. PATIENT WAS DIAGNOSED WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND MARGINAL LYMPHOMA IN THE GROIN ONLY. PATIENT IS RECEIVING ONGOING DIAGNOSTICS. PATIENT WAS TOLD HE HAD HEAVY METAL POISONING TO ALUMINUM AND SEVERAL OTHER METALS. THE IMPLANT SURGEON¿S OFFICE INFORMED THE PATIENT TODAY THAT HIS FEMUR DEVICE CONTAINED ALUMINUM. PATIENT WAS INFORMED THAT HE LIKELY WILL REQUIRE A REVISION TO HAVE THE IMPLANTS REMOVED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: High White Blood Cell Count; Lymphoma; Metal Related Pathology; Pain; Swollen Lymph Nodes/Glands

  MAUDE report 19351714 ↗
• MalfunctionDec 18, 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 18344531 ↗
• MalfunctionMay 16, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED UPON OPENING THE STERILE BOX, THERE WAS AN EYELASH INSIDE. 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 14406742 ↗

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-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.