DJO SURGICAL 940-01-48DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190446311393), received between Mar 18, 2026 and Jun 3, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K190057); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY - DUE TO FLUID CONSISTENCY WITH ALTR W POSITIVE DEBRIS METAL ION COBALT LEVEL ELEVATED CONVERSION REVISION SURGERY. LOOSE CUP UPON EVALUATION. DR. (B)(6) REPORTS: 1. REVISION SURGERY OF A FEMALE PATIENT WHO RECEIVED AN EMPOWR 48MM CUP WITH A DUAL MOBILITY BEARING, 3-4 YEARS POST-OP. 2. PRESENCE OF METALLOSIS AND DAMAGED BONE IN THE PELVIS THAT ALMOST CREATED A DISCONTINUITY. 3. LINER WAS INSTALLED PERFECTLY (PROPERLY ALIGNED AND NOT CANTED). 4. PREOP FOR COBALT WAS VERY HIGH AND MRI SHOWED ALTR. PREOP ASPIRATION HAD WHITE FLUID WITH MINIMAL CELLS COUNTED MANUALLY.

  Patient problems: Joint Laxity; Metal Related Pathology

  MAUDE report 25369527 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  LOOSE CUP.

  Patient problems: Joint Laxity

  MAUDE report 24635008 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190057. One submission often covers many models, so check the product and lot details in each record.

• Z-1234-2026 · Jan 5, 2026 · Open, Classified
  EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01
• Z-0103-2024 · Aug 22, 2023 · Open, Classified
  EMPOWR Acetabular System, Liner, 10 Hooded, HXe+, 40H, REF: 942-01-40H
• Z-0125-2023 · Aug 12, 2022 · Open, Classified
  EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
• Z-0135-2021 · Sep 9, 2020 · Open, Classified
  EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are
• Z-1929-2020 · Oct 22, 2019 · Open, Classified
  EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR Acetabular Impactor Balls is int