DJO SURGICAL 941-01-36HRecalls & reported problems
Encore Medical, L.P. · EMPOWR Acetabular System, Liner, Neutral, HXe+, 36H · 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 00190446309543), received between May 12, 2020 and Aug 4, 2026 — classified as 17 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. 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 Available3
- Device Dislodged or Dislocated2
- Unstable2
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Unspecified Infection9
- Joint Dislocation4
- Bone Fracture(s)1
- Joint Laxity1
- No Code Available1
- Pain1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem
InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem
InjuryMay 15, 2026Device Dislodged or Dislocated
InjuryMay 14, 2026Unstable
InjuryMar 23, 2026Device Dislodged or Dislocated
InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 28, 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
InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PERIPROSTHETIC FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 21648750 ↗InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 16, 2022Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - FEMORAL STEM SUBSIDED AND WAS LOOSE CAUSING ANTERIOR HIP PAIN.
Patient problems: Pain
MAUDE report 15235802 ↗InjuryApr 25, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INFECTION POLY EXCHANGE WAS DONE.
Patient problems: Unspecified Infection
MAUDE report 14193270 ↗InjuryApr 12, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INFECTION AND DRAINAGE FROM HIP. HEAD AND LINER EXCHANGE.
Patient problems: Unspecified Infection
MAUDE report 14085988 ↗InjuryOct 1, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT WAS INFECTED.
Patient problems: Unspecified Infection
MAUDE report 10613648 ↗InjuryMay 12, 2020Unstable
REVISION SURGERY - DUE TO PATIENT HIP UNSTABLE.
Patient problems: No Code Available
MAUDE report 10048898 ↗
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 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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