EMPHASYS 4742-04-200Recalls & reported problems
Depuy (Ireland) · EMPHASYS 12/14 FEMORAL STEM COLLARED HIGH OFFSET HA COATED 4 HO · Class 2 · Implant
All models of EMPHASYS (109)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295505556), received between Mar 7, 2024 and Aug 28, 2024 — classified as 2 injuries.
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 Problem2
Patient problems
- Limb Fracture2
- Pain1
- Seroma1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6). STUDY NO: DOTS. ASSOCIATED STUDY: PINNACLE CUP. DATE OF EVALUATION: (B)(6) 2024. DATE OF ONSET: (B)(6) 2024. OPERATIVE SIDE: RIGHT. DIAGNOSIS: HIP PAIN WITH AMBULATION. ADVERSE EVENT: PERIPROSTHETIC FRACTURE - FEMORAL. SPECIFY: NONDISPLACED GREATER TROCH FX. COUNTRY: US. SERIOUS: NO. DEVICE RELATED: REMOTE POSSIBILITY. PROCEDURE RELATED: REMOTE POSSIBILITY. ADDITIONAL EVENT INFORMATION: ON (B)(6) 2024, MEDICAL RECORDS NOTE THAT THE PATIENT IS 17 DAYS POSTOP RIGHT ANTERIOR TOTAL HIP ARTHROPLASTY. PATIENT PRESENTS WITH PAIN, RADIATING DOWN TOWARDS KNEE. PATIENT HAS A MODERATE-SIZED POSTOPERATIVE SEROMA. A RADIOGRAPH WAS NOTED TO SHOW SMALL CRACK AROUND THEIR GREATER TROCHANTER WITH NO DISPLACEMENT. ON (B)(6) 2024, MEDICAL RECORDS NOTE THE PATIENT IS 6 WEEKS POST RIGHT TOTAL HIP ARTHROPLASTY. THE PATIENT HAD A TROCHANTERIC FRACTURE AROUND 2 ½ WEEKS AND WENT TO 50% WEIGHTBEARING WITH A WALKER. THE CLINICAL IMPRESSION NOTES THE PATIENT IS PROGRESSING WELL. THE PATIENT IS TO CONTINUE USING THE WALKER AND CONTINUE ORAL MEDICATION.
Patient problems: Limb Fracture; Pain; Seroma
MAUDE report 20086226 ↗InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC FRACTURE - FEMORAL. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2024; DATE OF EVENT: (B)(6) 2024; (LEFT HIP). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.
Patient problems: Limb Fracture
MAUDE report 18861448 ↗
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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