DJO SURGICAL 942-01-36GRecalls & reported problems
Encore Medical, L.P. · EMPOWR Acetabular System, Liner, 10° Hooded, HXe+, 36G · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00190446309772), received between Dec 10, 2020 and Jun 2, 2026 — classified as 10 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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 Problem5
- Appropriate Device Problem Term/Code Not Available4
- Device Dislodged or Dislocated1
- Unstable1
Patient problems
- Unspecified Infection5
- Insufficient Information2
- Hematoma1
- Joint Laxity1
- Seroma1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2026Unstable; Device Dislodged or Dislocated
REVISION SURGERY DUE TO DISLOCATION / INSTABILITY.
Patient problems: Joint Laxity
MAUDE report 25368566 ↗InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
INFECTION OCCURRED, TOOK LINER AND HEAD OUT, WASHED AND CLEANED.
Patient problems: Unspecified Infection
MAUDE report 25130729 ↗InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT DEVELOPED SOME SORT OF SEROMA IN HIS HIP. IRRIGATION AND DRAINAGE WAS DONE WITH HEADLINER EXCHANGE.
Patient problems: Seroma
MAUDE report 15365306 ↗InjuryFeb 17, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: DUE TO INFECTION, SWAPPED OUT.
Patient problems: Unspecified Infection
MAUDE report 13548626 ↗InjuryDec 28, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT HAD JOINT INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 13096018 ↗InjuryNov 7, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO HIP WASHOUT, HEMATOMA, POST OPERATIVE, NEW IMPLANTS PROVIDED.
Patient problems: Hematoma
MAUDE report 12762241 ↗InjuryFeb 15, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO SKIN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 11330305 ↗InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS TREATED FOR POSSIBLE INFECTED JOINT.
Patient problems: Unspecified Infection
MAUDE report 10985076 ↗
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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