DJO SURGICAL 941-01-36ERecalls & reported problems
Encore Medical, L.P. · EMPOWR Acetabular System, Liner, Neutral, HXe+, 36E · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Encore Medical EMPOWR hip replacement liner is a plastic insert used inside an artificial hip joint. Reports mostly describe the hip becoming infected or dislocating after surgery, with several patients needing revision surgery for infection. There are 43 adverse event reports, all describing injuries and no deaths, and none name a problem with the liner itself. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 44
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00190446309512), received between Aug 25, 2020 and Sep 13, 2026 — classified as 44 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem31
- Appropriate Device Problem Term/Code Not Available7
- Device Dislodged or Dislocated3
- Unstable3
- No Apparent Adverse Event1
Patient problems
- Unspecified Infection28
- Joint Dislocation8
- Insufficient Information2
- Joint Laxity2
- Medical device site infection2
- Bacterial Infection1
- Fall1
- Implant Pain1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
InjurySep 13, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50747927 ↗InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem
InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
InjuryMay 26, 2026Device Dislodged or Dislocated
InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 29, 2026Device Dislodged or Dislocated
REVISION SURGERY DUE TO PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY AND AFTERWARDS EXPERIENCED TWO POST-OPERATIVE HIP DISLOCATION EVENTS.
Patient problems: Joint Dislocation
MAUDE report 25025937 ↗InjuryApr 24, 2026Device Dislodged or Dislocated
InjuryMar 30, 2026Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem
PT WAS BROUGHT BACK TO THE OR FOR INFECTION. SURGEON WANTED TO DO A HEAD LINER EXCHANGE.
Patient problems: Unspecified Infection
MAUDE report 24693909 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 23, 2026Unstable
InjuryJan 7, 2026Unstable
InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH RESULTED IN A POLY SWAP AND DEBRIDEMENT.
Patient problems: Unspecified Infection
MAUDE report 23366095 ↗InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO SUSPECTED INFECTION/POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 21915082 ↗InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT WAS EXPERIENCING PAIN AND POSSIBLE INFECTION.
Patient problems: Implant Pain; Unspecified Infection
MAUDE report 21370557 ↗InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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, ClassifiedEMPOWR 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, ClassifiedEMPOWR Acetabular System, Liner, 10 Hooded, HXe+, 40H, REF: 942-01-40H
- Z-0125-2023 · Aug 12, 2022 · Open, ClassifiedEMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
- Z-0135-2021 · Sep 9, 2020 · Open, ClassifiedEMPOWR 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, ClassifiedEMPOWR 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
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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