DJO SURGICAL 940-02-52FRecalls & reported problems
Encore Medical, L.P. · EMPOWR Acet System, Cup, Hemispherical, Cluster Hole, 52mm · Class 2 · Implant
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00190446311560), received between Sep 2, 2020 and Jun 30, 2026 — classified as 22 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem17
- Appropriate Device Problem Term/Code Not Available4
- Device Dislodged or Dislocated2
- Unstable1
Patient problems
- Joint Dislocation8
- Joint Laxity6
- Insufficient Information5
- Fall2
- Bone Fracture(s)1
- No Known Impact Or Consequence To Patient1
- Unspecified Infection1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT FELL AND NEEDED COMPONENTS REPLACED. STEM WAS LEFT IN PLACE.
Patient problems: Fall
MAUDE report 25673185 ↗InjuryJan 13, 2026Device Dislodged or Dislocated
InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - REVISED CUP TO ZIMMER BIOMET, NEEDED NEW HEAD.
Patient problems: Insufficient Information
MAUDE report 22538518 ↗InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL AND DISLOCATED.
Patient problems: Fall; Joint Dislocation
MAUDE report 21532043 ↗InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO CUP MOVED.
Patient problems: Insufficient Information; Joint Laxity
MAUDE report 19640112 ↗InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO CUP REVISION. REPLACED THE CUP WITH MULTIHOLE CUP.
Patient problems: Insufficient Information
MAUDE report 19274425 ↗InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; 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
InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO MALPOSITIONED IMPLANT.
Patient problems: Joint Laxity
MAUDE report 16052250 ↗InjuryNov 29, 2021Appropriate Device Problem Term/Code Not Available
InjuryOct 18, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Insufficient Information
MAUDE report 12651027 ↗InjurySep 20, 2021Unstable; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 12500475 ↗InjurySep 2, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10482772 ↗
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 Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented devices
- DJO SURGICAL 942-01-40HEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented2 recalls23 reports
- 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.