DJO SURGICAL 803-00-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912088541), received between Sep 10, 2018 and May 14, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2021Break

  PRODUCT FAILLURE - THE TIP OF THE THREADED STEM INSERTER HANDLE BROKE OFF AND IS NO LONGER USABLE BECAUSE IT PHYSICALLY CANNOT THREAD INTO A TAPER FILL OR LINEAR STEM.

  Patient problems: Insufficient Information

  MAUDE report 11829532 ↗
• MalfunctionOct 7, 2020Break

  INSTRUMENT FAILURE - SURGEON BROUGHT BACK A PATIENT SHOWING INFECTION SYMPTOMS. THE DECISION WAS MADE TO REMOVE ALL PRIMARY HIP COMPONENTS UNTIL INFECTION CLEARED. IN AN ATTEMPT TO REMOVE THE LINEAR FEMORAL STEM IMPLANT, THE THREADED INSERTER HANDLE WAS SCREWED INTO THE IMPLANT AND USED TO EXPLANT THE STEM. DURING THE ATTEMPT TO EXPLANT THE THREADS ON THE HANDLE BROKE OFF. ALL PARTS WERE REMOVED AND THE EXTRACTION CONTINUED TO NO ADVERSE EVENTS.

  Patient problems: Unspecified Infection

  MAUDE report 10641883 ↗
• MalfunctionSep 10, 2018Break; Detachment of Device or Device Component

  INSTRUMENT FAILURE - DURING IMPACTION OF FEMORAL HIP IMPLANT, INTO THE FEMORAL CANAL, THE TIP OF THE INSERTER BROKE OFF. THE IMPLANT WAS SUCCESSFULLY INSERTED INTO THE CANAL ALONG WITH THE BROKEN TIP INSIDE THE IMPLANT'S THREADED HOLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7862103 ↗