EMPHASYS 4710-48-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295500582), received between Aug 3, 2023 and Aug 31, 2026 — classified as 19 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Migration” (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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50522525 ↗
• MalfunctionMay 14, 2026Difficult to Insert

  IT WAS REPORTED THAT ACETABULAR IMPLANT DID NOT FIXATE AFTER TRYING SEVERAL TIMES. A BIGGER SHELL WAS OPENED TO CONTINUE PROCEDURE. THE DOCTOR WANTED THE IMPLANT TO BE ANALYZED FOR ANY DEFICIENCIES. AFFECTED SIDE-UNKNOWN HIP.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171466 ↗
• InjuryApr 13, 2026Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION OF HIP. MORE STABILITY WAS NEEDED. VERSION AND INCLINATION WAS ADJUSTED WITH NEW CUP AND DUAL MOBILITY WAS USED. THE PREVIOUS UP WAS REMOVED AND A NEW CUP PUT IN AT BETTER VERSION AND INCLINATION. DUAL MOBILITY WAS USED. CUP WAS WELL FIXED JUST IMPLANTED VERTICALLY PREVIOUSLY. DOI: UNKNOWN . DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24861206 ↗
• InjuryApr 13, 2026Osseointegration Problem

  IT WAS REPORTED THAT ASEPTIC LOOSENING OF CUP. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24858398 ↗
• MalfunctionJan 6, 2026Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT EMPHASYS 48 3-HOLE CUP OUTER PEEL PACK TORE AND CONTAMINATED INNER STERILE PACK. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977726 ↗
• InjuryDec 1, 2025Noise, Audible; Migration; Noise, Audible; Migration

  IT WAS REPORTED THAT PATIENT HEARD A POP AFTER SURGERY AND HER CUP SHIFTED. IT DID NOT HAPPEN IN SURGERY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23679532 ↗
• InjuryOct 30, 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. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23423280 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO EMPHASYS CUP THAT WAS UNABLE TO THREAD OFF OF THE EMPHASYS IMPACTOR HANDLE WHILE IN THE PATIENT. THE DOCTOR WENT UP A SIZE WITH THE SAME HANDLE, THE NEXT CUP SIZE DIDN'T HAVE AN ISSUE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280483 ↗
• MalfunctionMay 12, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE EMPHASYS CUP OPENED AND HAD A FOREIGN BLUE MATERIAL ON THE GRIPTION COATING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003645 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND THE SURGEON PULLED CONSTRUCT FOR INFECTION. THE SURGEON PUT IN PROSTALAC INSTEAD. THERE WAS NO IMPLANT FAILURE, NO LOOSENING, NO BROKEN IMPLANTS. THERE WERE NO PIECES LEFT BEHIND. THERE WAS NO SURGICAL DELAY. THERE WERE NO COMPLAINTS FROM SURGEON. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21953459 ↗
• MalfunctionApr 3, 2025Manufacturing, Packaging or Shipping Problem; Wrong Label; Manufacturing, Packaging or Shipping Problem; Wrong Label

  IT WAS REPORTED THAT THE SURGEON ASKED FOR A 48 EMPHASYS SHELL AND THE IMPLANT INSIDE CONTAINED A 54 EMPHASYS SHELL. BOX AND STICKERS INSIDE THE BOX WERE LABELLED 48 MM. IT WAS NOT IMPLANTED. SURGICAL DELAY WAS UNKNOWN. DOE: UNKNOWN AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21764329 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21733705 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN INFECTION. I&D HEAD LINER EXCHANGE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21707351 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION OF TOTAL HIP FOR INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21333513 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FRACTURED HER PELVIS AND THUS NEEDED TO REVISE THE CUP. THERE WAS NOTHING WRONG WITH THE IMPLANTS THEMSELVES. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 21306363 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF A RIGHT TOTAL HIP FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21150620 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS A KNOWN INFECTION. I&D WITH HEAD, CUP & LINER EXCHANGE PERFORMED. NO CASE DELAY, NO ADVERSE EFFECTS, NO BROKEN INSTRUMENTS OR IMPLANTS. DOI- (B)(6) 2024 DOR- (B)(6) 2024 AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20577978 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). IT WAS REPORTED THAT THE STUDY PATIENT UNDERWENT SURGERY FOR THE LEFT KNEE. CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PE. DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: PROBABLY. DATE OF EVENT: AUGUST 20, 2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: NO INFORMATION PROVIDED.

  Patient problems: Pulmonary Embolism

  MAUDE report 20438319 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR DVT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2024. DATE OF EVENT: 12 JUN 2024. (LEFT KNEE). TREATMENT: ORAL MEDICATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19624885 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION - SUPERFICIAL. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: 31 JAN 2024 (RIGHT HIP). TREATMENT: IRRIGATION AND DEBRIDEMENT

  Patient problems: Unspecified Infection

  MAUDE report 18694459 ↗
• InjuryNov 1, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CUP LOOSENING AND NEEDED TO BE REVISED. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18049028 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ACETABULAR PERIPROSTHETIC FRACTURE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023, DATE OF EVENT: (B)(6) 2023, (RIGHT HIP). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 17698300 ↗
• InjuryAug 8, 2023Migration; Migration

  PATIENT HAD PEVIS FX AND CUP MIGRATED INTO PEVIS. PULLED THE CUP AND PUT IN A CAGE. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023. DOR:(B)(6) ,2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 17483458 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Migration; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Migration

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO MALPOSITION/NON UNION TROCHANTER. DATE OF IMPLANT: (B)(6) 2023. DATE OF REVISION: (B)(6) 2023. (RIGHT HIP). TREATMENT: HEAD, LINER, STEM, AND CUP WERE REVISED.

  Patient problems: Bone Fracture(s); Fall; Hematoma; Inadequate Osseointegration; Pain

  MAUDE report 17450944 ↗