DJO SURGICAL 941-01-36GRecalls & reported problems
Encore Medical, L.P. · EMPOWR Acetabular System, Liner, Neutral, HXe+, 36G · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00190446309536), received between Jul 1, 2020 and Apr 10, 2026 — classified as 18 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 Problem14
- Appropriate Device Problem Term/Code Not Available3
- Device Dislodged or Dislocated3
- Unstable2
Patient problems
- Unspecified Infection10
- Insufficient Information2
- Joint Dislocation2
- Joint Laxity2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Medical device site infection1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem
SURGEON SUSPECTED THE PATIENT HAD AN INFECTION AND ELECTED TO DO AND I&D WITH HEAD, STEM AND POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 24845415 ↗InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 16, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY//LINER SWAP.
Patient problems: Joint Laxity
MAUDE report 19757634 ↗InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 10, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION. HEAD AND POLY EXCHANGE.
Patient problems: Medical device site infection
MAUDE report 15589010 ↗InjuryJul 21, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PATIENT DISLOCATED TWICE. THE SURGEON REPLACED THE NEUTRAL 36MM LINER WITH A PLUS 4 F10 DEGREE FACE TO CHANGE. ALL DJO PRODUCTS WORKED AS EXPECTED.
Patient problems: Insufficient Information
MAUDE report 15077248 ↗InjuryJan 18, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Insufficient Information
MAUDE report 13284496 ↗InjuryNov 29, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT DISLOCATED. SURGEON REPLACED A 36 MM NEUTRAL LINER WITH 40 PLUS 4 FACE CHANGING LINER.
Patient problems: Joint Dislocation
MAUDE report 12882830 ↗InjuryOct 1, 2021Device Dislodged or Dislocated
REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12561837 ↗InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS INFECTED SO SURGEON WASHED IT OUT AND SWAPPED THE LINER.
Patient problems: Unspecified Infection
MAUDE report 11037237 ↗InjuryJul 1, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10217612 ↗
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 Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented devices
- DJO SURGICAL 942-01-40HEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented2 recalls23 reports
- Vivacit-E® 110031012Zimmer, Inc. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall33 reports
- G7® Dual Mobility Acetabular System 110024462Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall22 reports
- DJO SURGICAL 942-01-36HEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall5 reports
- DJO SURGICAL 942-01-36JEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall1 report
- DJO SURGICAL 942-01-32CEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall0 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145150Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented46 reports
- TAPERLOC COMPLETE MICRO PRIMARY FEMORAL 51-106160Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented35 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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