EMPHASYS 4742-07-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295505570), received between Nov 14, 2022 and Mar 20, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT ARTHROPLASTY ON (B)(6) 2024. BROACHING OF THE FEMUR WAS COMPLETED SEQUENTIALLY FROM THE STARTER BROACH THROUGH TO THE FINAL BROACH SIZE; CALCAR REAMING WAS PERFORMED ON THE FINAL BROACH. EACH BROACH WAS FULLY SEATED WITHIN THE FEMUR. AFTER TRIALING WAS PERFORMED, THE SURGEON WAS HAPPY WITH STABILITY AND IMPLANT POSITIONING. FINAL STEM WAS CHOSEN, CONFIRMED BY SURGEON, AND OPENED. DURING STEM INSERTION, THE SURGEON FOUND A FRACTURE OF THE FEMUR. THE FRACTURE WAS DESCRIBED TO HAVE SPIRALED DISTALLY. STEM WAS REMOVED FROM THE FEMUR USING EXTRACTION INSTRUMENTS. NON DPS CABLES WERE OPENED AND USED TO STABILIZE THE FRACTURE. STEM WAS RE-INSERTED INTO THE FEMUR UNTIL IT WAS FULLY SEATED IN THE FEMUR WITH THE COLLAR SEATED AGAINST THE CALCAR. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: Limb Fracture

  MAUDE report 21653040 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT FELL POST OP DAY 2. PERIPROSTHETIC FRACTURE OF THE FEMUR. EMSYS STEM WAS REMOVED AND RECLAIM WAS IMPLANTED. FEMUR WAS CABLED, WIRED, AND STRUTTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 21459396 ↗
• InjuryNov 27, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  SUBJECT ID: (B)(4). STUDY NO: DOTS: CLINICAL ADVERSE EVENT RECEIVED FOR INCREASED PAIN AND ABNORMAL RADIOGRAPHIC EVALUATION. THE PATIENT WAS SEEN IN CLINICAL SETTING 3 MONTHS POST RIGHT ANTERIOR TOTAL HIP. IN HIS PRIOR VISIT AT 6 WEEKS POST-OP, IT WAS DISCOVERED THAT THE PATIENT HAD EXPERIENCED A NONDISPLACED BONE FRACTURE OF HIS RIGHT GREATER TROCHANTER, WITH PAIN. HE HAS SINCE HAD TWO FALLS, AND INCREASED PAIN--TO SUCH AN EXTENT THAT HE NOW HAS DIFFICULT WALKING AND CAN NO LONGER BEAR WEIGHT ON THE RIGHT HIP. RADIOGRAPHS OF THE RIGHT HIP APPEAR TO POSSIBLY SHOW THE FEMORAL STEM IMPLANT HAVING ROTATED FROM ITS ORIGINAL POST-OPERATIVE POSITION, POSSIBLY RELATED TO LOOSENING OF THE FEMORAL STEM IMPLANT. INDICATES FALL, PAIN, IMPLANT MIGRATION AND IMPLANT LOOSENING AT BONE TO IMPLANT INTERFACE. PRESENTLY, NO INVASIVE INTERVENTIONS--LAB WORK AND CT SCAN ARE TO BE ORDERED FOR CONTINUED EVALUATION. DEVICE RELATEDNESS: POSSIBLY PROCEDURE RELATEDNESS: DEFINITELY NOT DATE OF EVENT:6/NOV/2024 . DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: PRESENTLY, NO INVASIVE INTERVENTIONS--LAB WORK AND CT SCAN ARE TO BE ORDERED FOR CONTINUED EVALUATION. DEPUY COMPONENTS USED IN PROCEDURE WITHOUT DATE OF REV

  Patient problems: Ambulation or Postural Difficulties; Fall; Inadequate Osseointegration; Limb Fracture; Pain

  MAUDE report 20795819 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: THIS WAS A PRIMARY HIP SURGERY WITH FX OF HIS TROCHANTER POST OP WITH NO TREATMENT. CLINIC VISIT ON (B)(6) 2024 STATES THE PATIENT WAS 6 WEEKS OUT FROM A PRIMARY THA THAT WAS PERFORMED TO TREAT AVN. THE SURGEON STATES, "6 YEARS" BUT IT CAN BE ASSUMED THIS IS AN ERROR AS THIS IS A POST-OP VISIT. THE PATIENT SUSTAINED A TROCHANTERIC FRACTURE INTRAOPERATIVELY BUT THERE IS NO INDICATION WHAT THE TREATMENT WAS. XRAYS CONFIRM THERE IS A FRACTURE THAT IS MINIMALLY DISPLACED. THE PATIENT IS STATED TO BE DOING WELL AND CURRENTLY IN REHAB. *BECAUSE IT IS NOTED THAT THE FRACTURE OCCURRED INTRAOPERATIVELY, IT CAN BE ASSUMED THAT IMPLANT DATE AND EVENT DATE SHOULD BE (B)(6) WHICH IS 6 WEEKS PRIOR TO THE CLINIC VISIT.

  Patient problems: Limb Fracture

  MAUDE report 20291393 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SALES REP REMOVED ALL COMPONENTS IN THE HIP DUE TO INFECTION AND REPLACED WITH AN ANTIBIOTIC SPACER. THE HEADBALL AND LINER WERE EXCHANGED ON (B)(6) 2023 (COMPLAINT #: (B)(4)) IN (B)(6) INFECTION WOULD CLEAR. IT DIDN¿T SO EVERYTHING WAS REMOVED. NO ADDITIONAL TIME WAS ADDED. NO CEMENT USED IN INITIAL OR HEADBALL LINER EXCHANGE SURGERIES. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18695202 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR PE. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6)2021 DATE OF EVENT: (B)(6)2021 (LEFT HIP) TREATMENT: ORAL MEDICATION (XARELTO).

  Patient problems: Embolism/Embolus

  MAUDE report 17443324 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A PRIMARY TOTAL HIP REPLACEMENT BY A SURGEON IN COLORADO. A 56 EMPHASYS CUP, +4 NEUTRAL LINER, 36MM COBALT CHROME +5 HEAD AND SIZE 7 HIGH OFFSET EMPHASYS STEM WERE IMPLANTED. THE PATIENT SUFFERED A PERIPROSTHETIC FEMORAL FRACTURE AND WAS TREATED BY A REVISING SURGEON AT MARIGAN ARMY MEDICAL CENTER ON (B)(6) 23. THE REVISING SURGEON REMOVED THE FEMORAL HEAD AND STEM, CABLED THE FEMUR TO REDUCE THE FRACTURE, THEN IMPLANTED A STRYKER RESTORATION MODULAR STEM AND NEW FEMORAL HEAD. THE EMPHASYS CUP AND LINER FROM THE PRIMARY PROCEDURE WERE LEFT IN PLACE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 17058020 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POST OPERATIVE SCIATIC NERVE PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: (B)(6) 2021. (RIGHT HIP). TREATMENT: EXPLORATION WAS PERFORMED AND THERE WAS NO EVIDENCE OF TETHERING. THE NERVE WAS PALPATED AND FOUND TO BE FREE OF ANY TENSION.

  Patient problems: Nerve Damage; Pain; Physical Asymmetry

  MAUDE report 15788123 ↗