DJO SURGICAL 952-28-44GRecalls & reported problems
Encore Medical, L.P. · EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD44 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00190446673217), received between Jan 7, 2022 and May 5, 2026 — classified as 11 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K203557); 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 Problem6
- Appropriate Device Problem Term/Code Not Available4
- Insufficient Device Problem Information1
Patient problems
- Unspecified Infection9
- Insufficient Information1
- Medical device site infection1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryMay 5, 2026Insufficient Device Problem Information
REVISION SURGERY DUE TO REPLACE IMPLANTS / UNKNOWN REVISION REASON.
Patient problems: Insufficient Information
MAUDE report 25088962 ↗InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 14, 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 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS INFECTED. PERFORMED IRRIGATION & DRAINAGE WASHOUT.
Patient problems: Medical device site infection
MAUDE report 16026877 ↗InjuryMay 18, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INFECTION, IRRIGATION & DRAINAGE, SWAPPED POLY AND HEAD.
Patient problems: Unspecified Infection
MAUDE report 14429969 ↗InjuryApr 20, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS INFECTED.
Patient problems: Unspecified Infection
MAUDE report 14160851 ↗InjuryJan 24, 2022Appropriate Device Problem Term/Code Not Available
InjuryJan 7, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD INFECTION.
Patient problems: Unspecified Infection
MAUDE report 13198900 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K203557. One submission often covers many models, so check the product and lot details in each record.
- Z-2147-2025 · Jun 12, 2025 · Open, ClassifiedBrand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E Software Version: NA Product Description
- Z-2148-2025 · Jun 12, 2025 · Open, ClassifiedBrand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F Software Version: NA Product Description
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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