Total Hip Instrumentation 00-7804-015-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868550737), received between Feb 8, 2023 and Dec 14, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryDec 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT WHILE IMPLANTING THE ACETABULAR CUP, THE THREADS OF THE INSTRUMENT BROKE OFF INSIDE OF THE CUP. THE CUP HAD GOOD FIXATION, SO THE SURGEON DECIDED TO LEAVE THE CUP AS IT WAS, WITH NO CONSEQUENCES TO THE PATIENT. THE PATIENT¿S ANATOMY DID NOT CONTRIBUTE TO THE EVENT. IT WAS REPORTED THAT THE SURGICAL TECHNIQUE WAS USED. THERE WAS NO REPORTED PATIENT IMPACT, NO PATIENT INJURY, NO MEDICAL/SURGICAL INTERVENTIONS, NO SURGICAL DELAYS, NO FOREIGN BODY RETAINED, AND NO SURGICAL COMPLICATIONS. NO ADDITIONAL INFORMATION AVAILABLE.

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

  MAUDE report 18326184 ↗
• InjuryFeb 8, 2023Fracture; Fracture

  IT WAS REPORTED THAT WHILE USING THE CONTINUUM STRAIGHT HANDLE CUP INSERTER, THE THREADS BROKE OFF IN THE CUP DURING IMPLANTATION. THE FRAGMENT REMAINED IN THE PATIENT AND THE TRIAL LINER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE FINAL LINER. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16324057 ↗