DJO SURGICAL 940-02-54GRecalls & reported problems
Encore Medical, L.P. · EMPOWR Acet System, Cup, Hemispherical, Cluster Hole, 54mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00190446311577), received between Sep 2, 2020 and May 14, 2026 — classified as 18 injuries, 1 malfunction.
The most frequently reported specific device problem is “Unstable” (4 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
- Unstable4
- Device Dislodged or Dislocated2
- No Apparent Adverse Event2
- Appropriate Device Problem Term/Code Not Available1
- Osseointegration Problem1
- Patient-Device Incompatibility1
- Positioning Problem1
Patient problems
- Joint Dislocation6
- Joint Laxity5
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- Failure of Implant1
- Implant Pain1
- Limb Fracture1
- Loss of Range of Motion1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THER IMPLANT PACKING HAS YELLOWISH TINT AND DOCTOR WAS CONCERNED WITH USING IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25179180 ↗InjuryFeb 12, 2026Device Dislodged or Dislocated
InjuryDec 4, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem
IT WAS REPORTED THAT DUE TO IMPLANT LOOSENING AND INFECTION PATIENT REQUIRED REVISION SURGERY.
Patient problems: Septic loosening; Unspecified Infection
MAUDE report 23472678 ↗InjuryJun 16, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO WEAR AND INSTABILITY.
Patient problems: Joint Laxity
MAUDE report 22216168 ↗InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN.
Patient problems: Implant Pain; Loss of Range of Motion
MAUDE report 22015263 ↗InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 19924784 ↗InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO CUP SPUN OUT 8 DAYS POST OPT.
Patient problems: Insufficient Information
MAUDE report 19455659 ↗InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO FALL LOWER BODY COMPONENT, FRACTURE AND LOOSENING.
Patient problems: Joint Laxity; Limb Fracture
MAUDE report 19244723 ↗InjuryFeb 3, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 13, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 24, 2022No Apparent Adverse Event; No Apparent Adverse Event
PRIMARY SURGERY - CUP WAS INSERTED WITH STANDARD TECHNIQUE AND INSTRUMENTATION. LINER WOULD NOT SEAT PROPERLY. A TOTAL OF 3 LINERS WERE ATTEMPTED TO IMPLANT. A NEW CUP WAS OPENED AND LINER SEATED PROPERLY. ALL THREE OF THE LINERS LISTED WERE REMOVED ALONG WITH THE CUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15663108 ↗InjuryApr 27, 2021Unstable; Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - THE PATIENT HAS INSTABILITY IN THE HIP. THE CUP NEEDED TO BE REPOSITIONED. THE HIP KEPT DISLOCATING.
Patient problems: Failure of Implant
MAUDE report 11732021 ↗InjurySep 2, 2020Patient-Device Incompatibility; Positioning Problem; Patient-Device Incompatibility
COMPLAINT - DUE TO SHELL NOT SEATING PROPERLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10485432 ↗
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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