G7 OSSEOTI ACETABULAR SHELL 110010245Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304544208), received between Mar 22, 2021 and Jan 14, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED THAT THE PATIENT¿S OSSIFICATION SITE WAS SEEN ON PRE-OPERATIVE IMAGES AND THE PATIENT HAS BEEN THROUGH THE COURSE OF RADIOGRAPHIC IMAGING, INCLUDING A RECENT CT SCAN COMPLETED APPROXIMATELY TWO MONTHS AGO. IT WAS REPORTED THAT THERE WAS NO TRAUMA OR OTHER SPECIFIC CONTRIBUTING FACTORS WHICH COULD EXPLAIN THE SYMPTOMS. PATIENT WAS DESCRIBED AS A HEALTHY, FULLY COMPLIANT PERSON WITH GOOD MOTIVATION AND FOCUS ON POSTOP REHABILITATION. THE PATIENT HAS A NORMAL ACTIVITY LEVEL AND REGULAR CONTACT WITH PHYSIO. THE PATIENT IS NOW SCHEDULED TO HAVE AN ULTRASOUND GUIDED INJECTION AT THE OSSIFICATION SITE FOR DIAGNOSTIC PURPOSES. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Extraskeletal ossification; Pain

  MAUDE report 21154859 ↗
• MalfunctionJan 26, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THE CUP WAS IMPACTED INTO THE PATIENT. THE CUP SEEMED TO HAVE GOOD PURCHASE AND BE SOLID. AFTER TRIALING, THE HEAD AND LINER FROM THE BROACH, THE CUP WAS LOOSE. NOT RELATED TO THE QUALITY OF THE REAMING AND ACETABULUM. SCREWS WERE INSERTED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247128 ↗
• InjuryMar 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED A PULMONARY EMBOLISM APPROXIMATELY 2 MONTHS POST LEFT TOTAL HIP ARTHROPLASTY. THE PATIENT WAS HOSPITALIZED OVERNIGHT, TREATED MEDICALLY AND RESOLVED THE NEXT DAY. COMPONENTS REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pulmonary Embolism

  MAUDE report 13708213 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED A PULMONARY EMBOLISM APPROXIMATELY 2 MONTHS POST LEFT TOTAL HIP ARTHROPLASTY. THE PATIENT WAS HOSPITALIZED OVERNIGHT, TREATED MEDICALLY AND RESOLVED THE NEXT DAY. COMPONENTS REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pulmonary Embolism

  MAUDE report 13597819 ↗
• MalfunctionMar 22, 2021Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11542091 ↗