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DJO SURGICAL 940-03-50ERecalls & reported problems

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

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190446311713), received between Apr 4, 2023 and Sep 1, 2026 — 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem3

Patient problems

  • Joint Laxity2
  • Bone Fracture(s)1
  • Fall1

Recent adverse event reports

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

  • InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

    Patient problems: Bone Fracture(s); Fall

    MAUDE report 50554111 ↗
  • InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION DUE TO LOOSENING.

    Patient problems: Joint Laxity

    MAUDE report 20853688 ↗
  • InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - DUE TO LOOSENING.

    Patient problems: Joint Laxity

    MAUDE report 16679159 ↗

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 Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented devices

All Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.