EMPHASYS 4710-58-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295500636), received between Apr 21, 2023 and Sep 18, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50824056 ↗
• InjuryJun 30, 2026Osseointegration Problem

  IT WAS REPORTED THAT THE REMOVED A 58 EMPHASYS SHELL THAT WAS SAID TO BE LOOSE. IMPLANTED A 58 PINNACLE SECTOR SHELL INSTEAD. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25668042 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE TOTAL HIP, THE DOCTOR TOOK OUT THE FEMORAL HEAD AND STARTED REAMING WHILE USING X-RAY. HE REAMED TO A 52 AND TRIALED THE 52 CUP, BUT IT WASN¿T GETTING THE FIXATION HE LIKED SO REAMED UP TO A 54. THE SAME THING HAPPENED SO HE KEPT GOING UP AND TRIALING. HE WAS LOSING MEDIAL WALL AND DIDN¿T WANT TO EXPAND THE CUP VERY BIG SO HE WAS GOING TO CHANGE TO A BIPOLAR HEMI HEAD. WHILE TRIALING WITH THE BIPOLAR HEAD, IT WAS NOTICED THAT THE HEAD DIDN¿T WANT TO SEAT ALL THE WAY DOWN. SURGEON TOOK OUT THE TRIAL AND NOTICED THERE WAS A FRACTURE IN THE ACETABULUM. HE SCRUBBED OUT AND GOT SOME SUGGESTIONS FROM HIS PARTNER. HE ENDED UP DECIDING TO PUT IN A REAL STEM, AND A BIPOLAR HEAR IN WITHOUT THE METAL SHELL. THE PLAN WAS TO CLOSE AND COME BACK AND REVISE AT A LATER DATE WHEN THE DOCTOR HAD SOME HELP. ON (B)(6) 2025 THE HIP WAS REVISED. USED A REVISION CUP AND SCREWS AND GOT THE FIXATION THEY WANTED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s); Bone Notching

  MAUDE report 23535648 ↗
• InjuryAug 26, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT FELL DOWN THE STEPS AND THEIR CUP LOST FIXATION AND BECOME LOOSE. SURGEON REVISED THE CUP. THERE WAS LOOSENING OF 58- 3-HOLE ACETABULAR COMPONENT. THE LOOSENING INTERFACE WAS NONCEMENTED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 22895703 ↗
• MalfunctionJun 20, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE IMPACTED CUP, NO ISSUE, OPENED APPROPRIATE LINER, COULD NOT IMPACT. NO BONE OR SOFT TISSUE INTERFERENCE. OPENED SECOND LINER STILL HAD TROUBLE IMPACTING SECOND LINER. DIDN'T SEEM TO HAVE ANY DAMAGE TO CUP. NO THREADS FROM DOME, NO SOFT TISSUE OR BONE BETWEEN LOCKING MECHANISM. TRIED MULTIPLE ANGLES. EVENTUALLY WAS ABLE TO SEAT SECOND LINER. LISTING CUP AND LINER. ONLY WASTED LINER. DOE: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22299263 ↗
• 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 16823684 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOPERATIVE BLEED. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023, DATE OF EVENT: (B)(6) 2023, (RIGHT HIP). TREATMENT: COILING IS RECOMMENDED TO ADDRESS POTENTIAL LATERAL CIRCUMFLEX BLEED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16786623 ↗