EMPHASYS 4742-06-200Recalls & reported problems
Depuy (Ireland) · EMPHASYS 12/14 FEMORAL STEM COLLARED HIGH OFFSET HA COATED 6 HO · Class 2 · Implant
All models of EMPHASYS (109)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295505563), received between Apr 30, 2024 and Sep 29, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Migration” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Migration1
Patient problems
- Limb Fracture2
- Unspecified Infection2
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pain
MAUDE report 50935277 ↗InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SURGEON REMOVED ALL PREVIOUS IMPLANTS AND IMPLANTED A SPACER DUE TO INFECTION. NO TIME ADDED. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 22077288 ↗InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS REMOVED DUE TO INFECTION, SPACERS IMPLANTED, THERE WAS NO DELAY IN THE CASE AND THE PATIENT WAS NOT HARMED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 21130865 ↗InjuryMay 20, 2024Migration; Migration
SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR GREATER TROCHANTER FX WITH MINIMAL DISPLACEMENT. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE OR PROCEDURE. DATE OF IMPLANT: (B)(6) 2024. DATE OF EVENT: (B)(6) 2024. (LEFT HIP). TREATMENT: NONE.
Patient problems: Limb Fracture
MAUDE report 19351139 ↗InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC FRACTURE - FEMORAL. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2024. DATE OF EVENT: 15 APR 2024. (RIGHT HIP). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.
Patient problems: Limb Fracture
MAUDE report 19213146 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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