EMPHASYS 4742-08-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295505587), received between Apr 27, 2023 and Dec 2, 2024 — classified as 3 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 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 INCREASED PAIN AND SOME SWELLING IN THE RIGHT HIP DEVICE RELATEDNESS: POSSIBLY. PROCEDURE RELATEDNESS: REMOTE POSSIBILITY. DATE OF EVENT: 5/NOV/2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: ATTEMPT ASPIRATION OF HIP (PLANNED). PATIENT WAS SEEN IN THE CLINICAL SETTING ON (B)(6) 2024, AS PART OF HER STANDARD FOLLOW-UP. THREE WEEKS AFTER HER RIGHT HIP SURGERY, SHE GOT SEPTIC, HAD DIVERTICULITIS, PELVIC INFECTION AND A RESISTANT URINARY TRACT INFECTION. SHE HAS HAD A DIAGNOSED RIGHT GREATER TROCHANTER FRACTURE (NO SURGICAL TREATMENT PLANNED). SHE PRESENTS WITH PERSISTENT HIP PAIN TO THE TOUCH, ESPECIALLY ANTERIOR HIP, BUT NO SWELLING OR FLUID COLLECTION. HER X-RAYS AND LABS ARE NEGATIVE FOR ANY SIGNS OF IMPLANT FAILURE OR INFECTION. CLINICAL PLAN WAS TO ATTEMPT AN ASPIRATION OF HER HIP (MRI SHOWED A VERY SMALL FLUID COLLECTION IN THE JOINT) FOR EVALUATION OF POSSIBLE INFECTION.

  Patient problems: Inflammation; Limb Fracture; Pain; Swelling/ Edema; Unspecified Infection; Urinary Tract Infection

  MAUDE report 20817635 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR NON-DISPLACED MICRO CALCAR FRACTURE. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6)2023. DATE OF EVENT: (B)(6)2023. (LEFT HIP) TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Limb Fracture

  MAUDE report 17237791 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR GI; THROMBOSIS OF SUPERIOR MESENTERIC ARTERY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022, DATE OF EVENT: (B)(6) 2023, (LEFT HIP). TREATMENT: UNSPECIFIED TREATMENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16823667 ↗