EMPHASYS 4710-50-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295500599), received between Sep 23, 2024 and Sep 24, 2026 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Use of Device Problem; Improper or Incorrect Procedure or Method

  It was reported that the patient underwent the revision of an Emphasys cup due to dislocation. The cup was reported to have been implanted too steep/open and retroverted, and the event was described as surgeon error rather than implant fault.

  Patient problems: Insufficient Information

  MAUDE report 50884872 ↗
• InjurySep 8, 2026Osseointegration Problem

  It was reported that the patient was revised due to loose cup. Loosening interface was marked as the bone to implant.DOI: Unknown.DOR: (b)(6) 2026.Affected side: Unknown.

  Patient problems: Inadequate Osseointegration

  MAUDE report 50672071 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AS THE IMPLANTS WERE REMOVED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24428070 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS A PREEXISTING INFECTION. DOI-UNKNOWN, DOR- (B)(6) 2026 , AFFECTED SIDE-LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24365082 ↗
• InjuryFeb 5, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CUP WAS REVISED DUE TO ACETABULAR TRAUMA FROM A FALL. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Notching; Fall

  MAUDE report 24270818 ↗
• InjuryJan 21, 2026Migration

  IT WAS REPORTED THAT PATIENT HAD PAIN FROM BURSITIS, LOOKS LIKE CUP POSSIBLY MOVED POST OP. PATIENT WAS REVISED TO G7. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inflammation; Pain

  MAUDE report 24134456 ↗
• MalfunctionNov 25, 2025Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT THE CUP WOULD NOT SEAT APPROPRIATELY AFTER MULTIPLE TIMES REAMING TO CREATE A CLEAR PATH TO IMPLANT THE CUP. DOE: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645575 ↗
• InjuryJul 10, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT FELL POST THA. ACETABULAR FRACTURE. THERE WAS LOOSENING OF ACETABULUM, LOOSENING INTERFACE WAS NON-CEMENTED. ALL COMPONENTS WERE REVISED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 22466990 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. SURGEON WAS GOING TO SWAP THE HEAD AND LINER, BUT THE STEM CAME OUT EASILY, POSSIBLY DUE TO SEPSIS. THERE WAS NON-CEMENTED LOOSENING OF THE FEMUR. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 21880899 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME BACK TO THE HOSPITAL WITH DRAINING FROM HER TOTAL HIP DONE ONE WEEK AGO. DOCTOR BELIEVED THE JOINT TO BE INFECTED AND PLANNED TO WASH THE JOINT OUT, PLACE ANTIBIOTICS AND SWAP THE POLY AND HEAD WITH THE SAME IMPLANTS. WHILE REMOVING THE FEMORAL HEAD, THE STEM CAME OUT AS WELL. DOCTOR DECIDED TO REMOVE ALL IMPLANTS. DOCTOR USED A COMPETITOR CUP/LINER AND RE-IMPLANTED AN ACTIS AND CERAMIC HEAD. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 21873317 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025 DOR: (B)(6) 2025 AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21691828 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). 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; Pain; Swelling/ Edema; Unspecified Infection; Urinary Tract Infection

  MAUDE report 20817630 ↗
• InjuryNov 13, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED JOINT. THERE WAS NON-CEMENTED LOOSENING OF THE CUP, SUSPECTED FROM LYSIS AND INFECTION. EVERYTHING WAS EXPLANTED AND A SPACER WAS PUT IN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Osteolysis; Unspecified Infection

  MAUDE report 20676349 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20634997 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT : THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 20350515 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED: ON (B)(6) 2024, MEDICAL RECORDS NOTED THE PATIENT IS 6 WEEKS POST HIP ARTHROPLASTY. IT WAS SAID THAT THE PATIENT HAD A CT SCAN TWO WEEKS AGO AND IT SHOWED A PULMONARY EMBOLISM. THE PATIENT WAS PRESCRIBED ELIQUIS MEDICATION AND OVERALL IS DOING WELL. ON (B)(6) 2024, THE PATIENT IS NOW 3 ½ MONTHS OUT FROM A RIGHT TOTAL HIP IT WAS NOTED THAT THE PATIENT HAD A PE AFTERWARDS. DEPUY STEM AND CUP ARE REPORTED TO BE WELL PLACED ON A RADIOGRAPH.

  Patient problems: Pulmonary Embolism

  MAUDE report 20280872 ↗