DJO SURGICAL 952-28-38DRecalls & reported problems
Encore Medical, L.P. · EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD38 · 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 00190446673187), received between Nov 2, 2022 and Jun 25, 2026 — classified as 10 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 Problem8
- Device Dislodged or Dislocated1
- Patient Device Interaction Problem1
Patient problems
- Unspecified Infection4
- Joint Dislocation2
- Medical device site infection2
- Pain2
- Joint Laxity1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2026Device Dislodged or Dislocated
REVISION SURGERY - DUE TO DISLOCATION AND PAIN.
Patient problems: Joint Dislocation; Pain
MAUDE report 25628601 ↗InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO POSSIBLE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25628142 ↗InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 23, 2026Patient Device Interaction Problem
InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PT CAME TO CLINIC INFECTED; DR. COMPLETED A I&D WITH A HEAD LINER REPLACEMENT. 65 YRS FEMALE.
Patient problems: Unspecified Infection
MAUDE report 23843661 ↗InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD AN INFECTION SO THE LINER AND A COMPETITIVE COMPANY HEAD WAS REMOVED TO FACILITATE AN IRRIGATION AND DRAINAGE. A NEW LINER AND HEAD OF THE SAME TIME WAS THEN RE-IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 15772379 ↗InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Medical device site infection
MAUDE report 15716576 ↗
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-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
- 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
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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