DJO SURGICAL 942-01-40HRecalls & reported problems
Encore Medical, L.P. · EMPOWR Acetabular System, Liner, 10° Hooded, HXe+, 40H · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This DJO EMPOWR hip liner is part of a hip replacement. The 23 reports that name its identifier all mention injuries and no deaths, mostly describing infections leading to repeat surgery, with a few mentions of instability or dislocation. It has 2 open recalls about hip and knee parts being mixed up in packaging so the correct implant might not be available for surgery.
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
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00190446309833), received between Jun 26, 2020 and May 27, 2026 — classified as 23 injuries.
The most frequently reported specific device problem is “Packaging Problem” (2 reports).
2 FDA recall records name this device's identifier, 2 still open.
3 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
Recalls naming this device
- Aug 22, 2023Class IIOpen, Classified
Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
Z-0103-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗
- Aug 12, 2022Class IIOpen, Classified
Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
Z-0125-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem12
- Appropriate Device Problem Term/Code Not Available7
- Packaging Problem2
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
- No Apparent Adverse Event1
- Unstable1
Patient problems
- Unspecified Infection13
- Insufficient Information4
- Joint Laxity2
- Medical device site infection2
- Fall1
- Implant Pain1
- Joint Dislocation1
- Wound Dehiscence1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2026Insufficient Device Problem Information
REVISION SURGERY - DUE TO PATIENT UNSTABLE.
Patient problems: Insufficient Information
MAUDE report 25311150 ↗InjuryNov 20, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 2, 2024No Apparent Adverse Event; No Apparent Adverse Event
InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 28, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO WASHOUT OF AN INFECTION.
Patient problems: Medical device site infection
MAUDE report 16073758 ↗InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POSSIBLY INFECTION. PATIENT HAD PAIN.
Patient problems: Implant Pain; Medical device site infection
MAUDE report 15349695 ↗InjuryJun 22, 2022Packaging Problem
COMPLAINT - DURING SURGERY, TWO HIP LINER IMPLANT BOXES WERE CONSECUTIVELY OPENED TO FIND EMPOWR 3D KNEE INSERTS IN THE BOXES. SURGEON WANTED TO USE A 40MM, 10 DEGREE LINER, BUT WAS UNABLE. SURGEON HAD TO IMPLANT THE 40MM NON-HOODED LINER INSTEAD.
Patient problems: Insufficient Information
MAUDE report 14780969 ↗InjuryJun 22, 2022Packaging Problem
COMPLAINT - DURING SURGERY, TWO HIP LINER IMPLANT BOXES WERE CONSECUTIVELY OPENED TO FIND EMPOWER 3D KNEE INSERTS IN THE BOXES. SURGEON WANTED TO USE A 40MM, 10 DEGREE LINER, BUT WAS UNABLE. SURGEON HAD TO IMPLANT THE 40MM NON-HOODED LINER INSTEAD.
Patient problems: Insufficient Information
MAUDE report 14780967 ↗InjuryJan 11, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS INFECTED.
Patient problems: Unspecified Infection
MAUDE report 13231388 ↗InjuryNov 22, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY. HE HIKED 40 MILES AND DEVELOPED A SMALL DRAINING SINUS. SURGEON COMPLETED AN IRRIGATION & DRAINAGE.
Patient problems: Insufficient Information
MAUDE report 12853491 ↗InjuryNov 22, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT ENCOUNTERED INFECTION. CLEAN AND WASHOUT THE AREA OF INFECTION AND EXCHANGE CERAMIC HEAD AND LINER PARTS HAS BEEN DONE.
Patient problems: Unspecified Infection
MAUDE report 12853477 ↗InjuryAug 6, 2021Appropriate Device Problem Term/Code Not Available
InjuryJun 16, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT FELL AND INCISION OPENED. SURGEON DETERMINED IT WAS BEST TO PERFORM IRRIGATION & DRAINAGE AND REPLACE IMPLANTS TO MINIMIZE RISK OF INFECTION.
Patient problems: Fall; Wound Dehiscence
MAUDE report 12012188 ↗InjuryJan 3, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO POST OPERATION INFECTION.
Patient problems: Unspecified Infection
MAUDE report 11105641 ↗InjuryJun 26, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT HAD AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10200859 ↗
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-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
- 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
- iTotal® Hip Replacement System HBS033000001Conformis, Inc. · Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented33 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 · each recall links to the FDA recall notice
- 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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