DJO SURGICAL 942-01-40GRecalls & reported problems
Encore Medical, L.P. · EMPOWR Acetabular System, Liner, 10° Hooded, HXe+, 40G · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00190446309826), received between Mar 5, 2021 and Sep 11, 2026 — classified as 17 injuries.
The most frequently reported specific device problem is “Unstable” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
4 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
- Jan 5, 2026Class IIOpen, Classified
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Z-1234-2026 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem13
- Appropriate Device Problem Term/Code Not Available3
- Unstable2
- Device Dislodged or Dislocated1
Patient problems
- Unspecified Infection9
- Insufficient Information3
- Joint Laxity2
- Joint Dislocation1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
- Wound Infection1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Device Dislodged or Dislocated
Patient problems: Unspecified Infection
MAUDE report 50744263 ↗InjuryAug 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50509885 ↗InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
PATIENT BECAME INFECTED SHORTLY AFTER PRIMARY HIP ON (B)(6) 2026. REQUIRED I&D WITH LINER AND FEMORAL HEAD REVISION. ACETABULAR CUP AND FEMORAL STEM COMPONENTS REMAINED STABLE.
Patient problems: Unspecified Infection
MAUDE report 25476743 ↗InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFECTION. HEAD AND LINER SWAP WITH WOUND WASHOUT.
Patient problems: Unspecified Infection
MAUDE report 23858020 ↗InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT WAS DRAINING FROM THEIR INCISION POST OPERATIVELY. THE SURGEON DECIDED TO DO AN IRRIGATION AND DEBRIDEMENT OF THE HIP AND EXCHANGE THE POLY LINER AND CERAMIC HEAD WHILE HE WAS IN THE JOINT.
Patient problems: Insufficient Information; Wound Infection
MAUDE report 20467378 ↗InjurySep 5, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT HAD SURGERY PRIMARY 2 WEEKS AGO AND CONTINUED TO DRAIN AFTER. HE WASHED THIS WOUND OUT AND CHANGED THE HEAD AND LINER TO BE SAFE.
Patient problems: Insufficient Information
MAUDE report 18874134 ↗InjurySep 20, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT DISLOCATED. SURGEON EXCHANGED THE DJO LINER FOR A SIMMER BIOMET CONSTRAINED LINER AND CEMENTED AGAINST THE CUP.
Patient problems: Joint Dislocation
MAUDE report 15865046 ↗InjuryMar 7, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: DUE TO LOTS OF INFECTED TISSUE. SURGEON DECIDED TO SWITCH OUT LINER AND HEAD.
Patient problems: Unspecified Infection
MAUDE report 13684761 ↗InjuryOct 12, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - WASH OUT HEAD POLY EXCHANGE FOR INFECTION.
Patient problems: Unspecified Infection
MAUDE report 12618952 ↗InjuryMar 5, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO UNKNOWN REASONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11423558 ↗
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-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 · 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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