DJO SURGICAL 942-01-40JRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190446309857), received between Nov 29, 2022 and Jun 26, 2023 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 17206010 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO AN INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 15970222 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT WAS EXPERIENCING INSTABILITY BUT WAS ALSO INFECTED.

  Patient problems: Joint Laxity; Medical device site infection

  MAUDE report 15880074 ↗

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