DJO SURGICAL 803-15-142Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190446689843), received between Mar 24, 2022 and Mar 24, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K203557); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2022Therapeutic or Diagnostic Output Failure

  INSTRUMENT FAILURE WHILE TRAILING ON A TOTAL HIP, THE DUAL MOBILITY HEAD TRIAL WAS POSITIONING UP AND DOWN THE TRUNNION OF THE BROACH TRIAL, AND SURGEON WAS UNABLE TO CREATE ENOUGH TRACTION TO DISLOCATE THE HIP. SURGEON TOOK A POWER CORK SCREW AND DRILLED IT IN TO THE TRIAL AND THIS ALLOWED HIM TO DISLOCATE THE HIP.

  Patient problems: Insufficient Information

  MAUDE report 13893817 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K203557. One submission often covers many models, so check the product and lot details in each record.

• Z-2148-2025 · Jun 12, 2025 · Open, Classified
  Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F Software Version: NA Product Description
• Z-2147-2025 · Jun 12, 2025 · Open, Classified
  Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E Software Version: NA Product Description