EMPHASYS 4710-52-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295500605), received between Aug 8, 2023 and Jul 2, 2026 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25692686 ↗
• InjuryApr 30, 2026Osseointegration Problem

  IT WAS REPORTED THAT EMSYS LNR AOX ELV 52X36, UNK HIP FEMORAL HEAD CERAMIC, EMSYS SHL 3HOLE 52, PINN CAN BONE SCREW 6.5MMX35MM, AND UNKNOWN SCREW WERE INVOLVED IN A REPORTED EVENT. THE EVENT CONCERNED A PATIENT WHO UNDERWENT A DAIR (DEBRIDEMENT, ANTIBIOTICS, AND IMPLANT RETENTION) PROCEDURE DUE TO INFECTION FOLLOWING IMPLANTATION OF AN EMPHASYS CORAIL CONSTRUCT. DURING THE OPERATION, THE CUP WAS DESCRIBED AS LOOSE, BUT IT WAS NOT REMOVED BECAUSE THE PATIENT WAS LIKELY TO REQUIRE A MULTI-STAGE REVISION AND SCREWS WERE ALREADY IN PLACE. THE REPORTED FAILURE INCLUDED INFECTION AND IMPLANT LOOSENING. THE PATIENT EXPERIENCED HARM, REQUIRING REVISION OF THE LINER AND IMPLANTATION OF A NEW FEMORAL HEAD AS PART OF THE WASHOUT FOR INFECTION. EXTENDED HOSPITALIZATION WAS NECESSARY FOR SURGICAL INTERVENTION TO ADDRESS THE INFECTION. THE EVENT IS LIKELY TO RESULT IN FURTHER MULTI-STAGE REVISION PROCEDURES. THE IMPLANT STATUS FOR THE LINER AND FEMORAL HEAD IS EXPLANTED.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 25045914 ↗
• InjuryJan 16, 2026Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD A PERSISTENT INFECTION IN THEIR LEFT HIP. JOINT WAS WASHED OUT AGAIN AND THE HEAD AND LINER WERE GOING TO BE EXCHANGED, HOWEVER THE CUP CAME LOOSE WHEN TRYING TO EXTRACT THE LINER. THUS THE HEAD, LINER AND CUP WERE ALL EXCHANGED FOR A MODULAR UNIPOLAR BALL. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24097137 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. IMPLANTS WERE EXTRACTED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23908834 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT BECAME INFECTED ABOUT 4 WEEKS POST OP. DOCTOR OPTED TO PULL HARDWARE, RUN LABS AND USE AND MEDICATED TEMP SPACER. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23888284 ↗
• InjuryNov 4, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO LOOSE ACETABULAR CUP AND PAIN. MODERATE YELLOWING WAS NOTED ON THE ACETABULAR LINER.

  Patient problems: Pain

  MAUDE report 23463254 ↗
• MalfunctionOct 28, 2024Difficult to Insert; Material Deformation; Naturally Worn; Difficult to Insert; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT CUP WAS CROSS THREADED. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20544766 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT RIGHT HIP WAS REVISED ON (B)(6) 2024 DUE TO INFECTION OF TOTAL HIP ARTHROPLASTY. SURGEON REMOVED ALL COMPONENTS AND IMPLANTED 1ST STAGE PROSTALAC. (B)(6) 2024 WAS INITIAL DATE OF IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 20536988 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: ON (B)(6) 2024, THE PATIENT HAD A POST-OPERATIVE CLINIC VISIT. THE PHYSICIAN STATED THAT DUE TO THE OVERLAP OF ABDOMINAL TISSUE, THE INCISION SHOWS A COUPLE AREAS THAT LOOK MOIST AND MACERATED. THE PATIENT WAS TOLD TO TAKE ORAL ANTIBIOTICS AND EDUCATED TO KEEP THE WOUND DRIER BY COVERING WITH A LIGHT GAUZE. ON (B)(6) 2024, THE PATIENT HAD ANOTHER POST-OPERATIVE CLINIC VISIT. THE PHYSICIAN STATES THAT SHE HAD UNDERGONE AN EXPLORATION AND DEBRIDEMENT OF THE WOUND AND ¿THEN IT WAS JUST A SUPERFICIAL WOUND.¿ SHE CONTINUES TO HAVE A SMALL AREA ON THE MEDIAL SIDE WHICH WAS DEBRIDED ¿A BIT LAST TIME¿ AND IS SLOWLY HEALING. THE PATIENT IS OTHERWISE HEALING AND PROGRESSING WELL.

  Patient problems: Impaired Healing

  MAUDE report 20504673 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED: ON (B)(6) 2024, THE PATIENT WAS TREATED OPERATIVELY WITH IRRIGATION AND DEBRIDEMENT, AS WELL AS AN EXCISION/REVISION OF THE PREVIOUS SURGICAL SCAR¿THIS WAS ALL PART OF TREATMENT FOR A SUPERFICIAL WOUND INFECTION OF THE LEFT DIRECT ANTERIOR TOTAL HIP WOUND. THE INCISION WAS RED, SWOLLEN, AND TENDER. CULTURES TESTED POSITIVE FOR MRSA. THE INFECTION WAS ENTIRELY SUPERFICIAL WITH NO DEEP COMMUNICATION TRACTS. NO PRODUCTS WERE REVISED. THE PATIENT WAS SEEN CLINICALLY ON (B)(6)2024 FOR POST-OPERATIVE FOLLOW-UP. HER WOUND WAS HEALING WELL, AND THE RETENTION SUTURES PLACED ON (B)(6) 2024 WERE REMOVED FROM THE OFFICE.

  Patient problems: Discomfort; Erythema; Post Operative Wound Infection; Swelling/ Edema; Unspecified Infection

  MAUDE report 20324005 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO ACUTE INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20088276 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS CLINICAL ADVERSE EVENTS RECEIVED FOR INFECTION - DEEP DEVICE AND PROCEDURE(RELATEDNESS) DEVICE RELATED: REMOTE POSSIBILITY PROCEDURE RELATED: PROBABLY DATE OF IMPLANT: (B)(6) 2024 DATE OF REVISION: (B)(6) 2024 DEVICE LOCATION: LEFT TREATMENT/IMPACT: REVISION.

  Patient problems: Adhesion(s); Impaired Healing; Pain; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 20052166 ↗
• InjuryMay 14, 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 PERIPROSTHETIC FRACTURE - PELVIC. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2024. DATE OF EVENT: (B)(6) 2024. (RIGHT HIP) TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Limb Fracture

  MAUDE report 19313140 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HIP DISLOCATING AND UNSTABLE. REVISED SOCKET TO A DUAL MOBILITY WITH A LONGER NECK. DOI- (B)(6) 2023; DOR- (B)(6) 2024; AFFECTED SIDE- RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 18857618 ↗
• InjuryJan 4, 2024Migration; Migration

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL X-RAY; CUP MIGRATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF REVISION: UNK. DATE OF EVENT: 20 DEC 2023 (RIGHT HIP). TREATMENT: REVISION; CUP AND LINER WERE REVISED. REVISION DUE TO MIGRATION OF THE ACETABULAR CUP. IT IS REASONABLE TO CONCLUDE THE REVISED ACETABULAR LINER DID NOT CAUSE OR CONTRIBUTE TO THE MIGRATION OF THE ACETABULAR CUP AS MOVEMENT OCCURRED BETWEEN THE ACETABULAR CUP AND ACETABULUM. THERE ARE NO ALLEGED DEFICIENCIES WITH THE ACETABULAR LINER AND SCREWS AS THOSE IMPLANTS MUST BE REMOVED TO ADDRESS THE MIGRATION.

  Patient problems: Insufficient Information

  MAUDE report 18443739 ↗
• InjuryJan 4, 2024Migration; Migration

  PATIENT WAS REVISED DUE TO MEDIALLY MIGRATION OF CUP AT 3 MONTH CHECKUP. SURGEON PULLED THE CUP AND IMPLANTED REVISION CUP WITH ALLOGRAFT. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18442990 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOPERATIVE FX OF POSTERIOR WALL/POSTERIOR COLUMN ACETABULAR FX.. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. 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: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Bone Fracture(s); Unspecified Musculoskeletal problem

  MAUDE report 17479340 ↗