G7 OSSEOTI ACETABULAR SHELL 110010263Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304544383), received between Dec 7, 2018 and Oct 23, 2024 — classified as 3 injuries, 1 malfunction.

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

• MalfunctionOct 23, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE SURGERY THE SURGEON TRIED TO INSERT THE LINER INTO THE SHELL, HOWEVER IT WOULD NOT MATE. THE SURGEON MADE SURE THERE WAS NO SCREWS OR SOFT TISSUE KEEPING THE LINER FROM INSERTING. THE CUP AND LINER WERE NOT USED. 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 20516681 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO A POST-OP HEMATOMA AND DRAINING SINUS. THIS REQUIRED AN INCISION, DRAINAGE, ANTIBIOTICS AND JOINT DEBRIDEMENT. CONCLUDING THIS PROCEDURE, AN UNSPECIFIED INFECTION WAS NOTED. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS. APPROXIMATELY A MONTH LATER THE PATIENT EXPERIENCE CONTINUED WOUND DRAINAGE AND SIGNS OF AN INFECTION. THE PATIENT WAS COVID POSITIVE AND UNDERWENT A SECOND IRRIGATION AND DEBRIDEMENT ALONG WITH REPLACEMENT OF THE HEAD AND LINER. CULTURES FROM THIS REVISION SURGERY WERE POSITIVE FOR INFECTION AND PATIENT CONTINUED IV ANTIBIOTICS ALONG WITH FOLLOW UP CARE FROM AN INFECTIOUS DISEASE SPECIALIST.

  Patient problems: Bacterial Infection; Hematoma; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 16284965 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12512943 ↗
• InjuryDec 7, 2018Positioning Failure

  IT WAS REPORTED THAT THE LINER WOULD NOT SEAT IN CUP. DUE TO MALFUNCTION, SURGERY WAS DELAYED FOR MORE THAN 2 HOURS. PATIENT'S BONE WAS NOTED TO BE FRACTURED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 8141451 ↗