DJO SURGICAL 940-02-50ERecalls & reported problems
Encore Medical, L.P. · EMPOWR Acet System, Cup, Hemispherical, Cluster Hole, 50mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical EMPOWR hip cup is a porous, uncemented acetabular implant used in hip replacement. The 26 adverse event reports describe patients who needed revision surgery, mostly because the cup loosened or shifted, the hip dislocated or felt unstable, or metal parts wore against each other and released metal debris; a few involve falls with bone fractures or a broken implant. All reports describe injuries, with no deaths. No recalls name this device.
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
- 26
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00190446311553), received between Oct 13, 2020 and Apr 17, 2026 — classified as 26 injuries.
The most frequently reported specific device problem is “Unstable” (2 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 Problem21
- Unstable2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
- Migration or Expulsion of Device1
Patient problems
- Joint Laxity7
- Insufficient Information5
- Fall3
- Joint Dislocation3
- Bone Fracture(s)2
- Failure of Implant2
- Hip Fracture1
- Joint Impingement1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO IMPLANT IMPINGEMENT.
Patient problems: Joint Impingement
MAUDE report 24918866 ↗InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL AND HAD A PERIPROSTHETIC FRACTURE. DR. PUT IN A REVISION STEM AND CONVERTED THE CUP TO DUAL MOBILITY.
Patient problems: Bone Fracture(s); Fall
MAUDE report 23528608 ↗InjuryOct 29, 2025Unstable; Unstable
InjuryOct 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY TO REPLACE THE CUP.
Patient problems: Insufficient Information
MAUDE report 23286074 ↗InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS AN EMPOWER DUAL MOBILITY HIP IMPLANT. THE SURGERY WAS IN 2023 AND REVISED IN 2024 DUE TO HIGH LEVELS OF COBALT AND CHROMIUM. THE IMPLANT HAD ERODED.
Patient problems: Metal Related Pathology
MAUDE report 21440573 ↗InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO UNKNOWN REVISION REASON.
Patient problems: Insufficient Information
MAUDE report 21185865 ↗InjuryDec 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT HAD FELL AND THE CUP HAD BROOKE THROUGH THE MEDIAL WALL.
Patient problems: Insufficient Information
MAUDE report 19965922 ↗InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO LOOSENING AND INSTABILITY.
Patient problems: Joint Laxity
MAUDE report 19177649 ↗InjuryFeb 3, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - MDR - FALL LOWER BODY COMPONENT/FRACTURE.
Patient problems: Hip Fracture
MAUDE report 17909798 ↗InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - REVISION WAS COMPLETED WHERE CUP/LINER & HEAD BALL WERE REMOVED. NEW CUP/LINER/HEAD BALL IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 17761637 ↗InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE CUP WAS PUT IN TOO VERTICAL ORIGINALLY.
Patient problems: Limb Pain
MAUDE report 17206006 ↗InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE.
Patient problems: Failure of Implant
MAUDE report 17205997 ↗InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT DISLOCATED AND BECAUSE OF THAT THE REVISION OF THE CUP WAS CHANGED TO PREVENT THIS FROM OCCURRING AGAIN.
Patient problems: Joint Dislocation
MAUDE report 15970173 ↗InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD SURGERY EARLIER IN THE DAY AND SOMEHOW THE CUP SLIPPED OUT OF PLACE AND THE SURGEON DECIDED TO GO BACK IN AND REDO EVERYTHING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15439586 ↗InjuryJun 6, 2022Migration or Expulsion of Device; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY DUE TO THE CUP HAD GONE THROUGH THE PATIENT'S ACETABULAR WALL.
Patient problems: Insufficient Information
MAUDE report 14605633 ↗InjuryJul 8, 2021Device Dislodged or Dislocated
REVISION SURGERY - PATIENT FELL AND DISLODGED CUP. SURGEON DID A CUP REVISION AND USED HEAD BECAUSE HE RETAINED THE STEM.
Patient problems: Fall
MAUDE report 12139541 ↗
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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