DJO SURGICAL 942-01-36ERecalls & reported problems
Encore Medical, L.P. · EMPOWR Acetabular System, Liner, 10° Hooded, HXe+, 36E · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00190446309758), received between Feb 16, 2021 and Sep 15, 2026 — classified as 17 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 Problem9
- Appropriate Device Problem Term/Code Not Available4
- Device Dislodged or Dislocated3
- Unstable2
Patient problems
- Unspecified Infection11
- Joint Dislocation2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Discomfort1
- Hematoma1
- Implant Pain1
- Joint Laxity1
- Medical device site infection1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Device Dislodged or Dislocated
Patient problems: Unspecified Infection
MAUDE report 50781680 ↗InjuryAug 31, 2026Device Dislodged or Dislocated
InjuryOct 27, 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.
Patient problems: Unspecified Infection
MAUDE report 23399278 ↗InjuryOct 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN AND DISCOMFORT. X-RAYS SHOWED THAT THE HIP APPEARED TO BE SUBLUXED. SURGEON REMOVED THE HEAD AND LINER AND REPLACED THEM WITH A NEW 36 MM NEUTRAL HEAD AND A NEW 36E 10-DEGREE HOODED LINER.
Patient problems: Discomfort; Implant Pain; Subluxation
MAUDE report 23356076 ↗InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 8, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 23, 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 SWAP.
Patient problems: Medical device site infection
MAUDE report 15853825 ↗InjuryMay 18, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THIS PATIENT HAD INFECTION. SURGEON WANTED TO REPLACE THE LINER AND HEAD BALL AS WELL AS WASHING OUT THE HIP.
Patient problems: Unspecified Infection
MAUDE report 14429938 ↗InjuryFeb 18, 2022Appropriate Device Problem Term/Code Not Available
InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem
InjuryOct 13, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAS INFECTED HIP JOINT. SURGEON CHOSE TO WASHOUT JOINT AND REMOVE AND REPLACE FEMORAL HEAD AND LINER. THE 2 SCREWS FROM PRIMARY SURGERY WERE ALSO REMOVED.
Patient problems: Unspecified Infection
MAUDE report 12627213 ↗InjurySep 14, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT BECAME INFECTED SO WASH AND SWAP WAS DONE.
Patient problems: Unspecified Infection
MAUDE report 12469418 ↗InjuryMay 5, 2021Unstable
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11776855 ↗InjuryApr 15, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO POSSIBLE INFECTION, WE CHANGED THE HEAD AND LINER.
Patient problems: Unspecified Infection
MAUDE report 11671085 ↗InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT WAS THOUGHT TO HAVE AN INFECTION. THE SURGEON OPENED THE PATIENTS INCISION AND THERE WAS A HEMATOMA. THE SURGEON CLEANED OUT THE JOINT AND REPLACED THE FEMORAL HEAD AND LINER.
Patient problems: Hematoma; Unspecified Infection
MAUDE report 11332462 ↗
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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