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DJO SURGICAL 940-01-50ERecalls & reported problems

Encore Medical, L.P. · EMPOWR Acetabular System, Cup, Hemispherical, Solid Back, 50 · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190446311409), received between Sep 23, 2022 and Sep 23, 2022 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Bone Fracture(s)1

Recent adverse event reports

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

  • InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - ACETABULUM FRACTURE. MULTI HOLE CUP USED.

    Patient problems: Bone Fracture(s)

    MAUDE report 15470912 ↗

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

Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices

All PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices →

Sources and updates

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