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DJO SURGICAL 941-01-32ERecalls & reported problems

Encore Medical, L.P. · EMPOWR Acetabular System, Liner, Neutral, HXe+, 32E · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190446309475), received between Jun 14, 2022 and Jun 7, 2023 — classified as 2 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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Joint Laxity1
  • Unspecified Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - INSTABILITY.

    Patient problems: Joint Laxity

    MAUDE report 17083789 ↗
  • InjuryJun 14, 2022Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY- THE PATIENT HAS AN INFECTION. THERE WERE DELAYS DURING THE REMOVAL OF THE IMPLANTS. THE SURGEON HAD TROUBLE REMOVING THE STEM WITH THE DJO THREADED INSERTER. HE OPTED TO USE A DIFFERENT INSTRUMENT AND WAS ABLE TO PLANT THE STEM. HE ALSO HAD TROUBLE REMOVING THE CUP. HE USED A NON-DJO INSTRUMENT IN ORDER TO COMPLETE THE TASK. ALL TOLD, THESE INCIDENTS RESULTED IN AN HOUR DELAY FOR THE REVISION.

    Patient problems: Unspecified Infection

    MAUDE report 14690230 ↗

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.