NA 6250-65-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024119871), received between May 5, 2023 and May 5, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN INITIAL LEFT HIP ARTHROPLASTY, A SCREW SLIPPED THROUGH THE HOLE AND EMERGED PAST THE CAGE. THE SCREW WAS ABLE TO BE REMOVED WITHOUT INCIDENT AND WAS REPLACED WITH A COMPETITOR'S SCREW WHICH ALSO SLIPPED AND REMAINS IMPLANTED. OPERATIVE NOTES INDICATED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PREVIOUSLY REPORTED PATIENT IMPACT AND SERIOUS INJURY. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS HAVE BEEN MADE HOWEVER IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875608 ↗
• MalfunctionMay 5, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY. WHEN PLACING THE BONE SCREW IN THE ACETABULAR REGION, IT WAS NOTICED THAT THE SCREW HEAD SLIPPED THROUGH THE HOLE IN THE IMPLANT AND CAME TO REST BEHIND THE IMPLANT DURING FINAL TIGHTENING. THERE WAS A DELAY OF 120 MINUTES WHILE THE SURGEON ATTEMPTED TO REMOVE THE SCREW, BUT WAS UNABLE. THE SCREW REMAINS IN THE PATIENT. DUE DILIGENCE IS IN PROCESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875602 ↗