EXETER 0580-1-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04546540153210), received between Aug 30, 2018 and May 28, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Fracture” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: I HAVE BEEN USING BILATERAL HIP PROSTHESES FOR 8 YEARS. ON (B)(6) 2026, I BEGAN TO FEEL SPONTANEOUS PAIN IN MY HIP (RIGHT SIDE), AND THE PAIN PROGRESSED WITH LOSS OF STRENGTH AND MOBILITY IN THE LIMB. I WAS THEN TAKEN BY AMBULANCE TO THE HOSPITAL ON (B)(6) 2026, WHERE AN X-RAY REVEALED THAT THE PROSTHESIS WAS BROKEN. THIS OCCURRED SPONTANEOUSLY, WITHOUT ANY ASSOCIATED TRAUMA. SINCE THEN, MY LIFE HAS CHANGED REPEATEDLY, AS FROM THAT DAY ON I COULD NO LONGER WALK, WORK, OR PERFORM SIMPLE DAILY ACTIVITIES. I STARTED NEEDING HELP WITH EVEN SMALL NECESSITIES LIKE DRESSING, GOING TO THE BATHROOM, LYING DOWN, ETC. IN ADDITION TO THE SIGNIFICANT EMOTIONAL IMPACT ON ME AND MY FAMILY, I WAS PHYSICALLY AND FINANCIALLY AFFECTED BY HAVING TO BEAR THE COSTS OF MEDICAL EXPENSES AND MEDICATIONS, AND BY THE HEALTH DAMAGE RELATED TO THE SURGERY, AS I HAVE SICKLE CELL ANEMIA, WHICH REQUIRED GREATER CARE AND INVOLVED RISKS. I DID EXPERIENCE COMPLICATIONS AFTER THE PROSTHESIS REPLACEMENT SURGERY, DEVELOPING A PULMONARY THROMBOEMBOLISM, WHICH FURTHER WEAKENED MY HEALTH, REQUIRING OXYGEN AND PROLONGING MY HOSPITAL STAY. I ALSO NEEDED FOUR BLOOD TRANSFUSIONS. ALL OF

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 25315216 ↗
• InjuryMar 6, 2025Fracture; Fracture

  IT WAS REPORTED BY THE SALES REP. THAT: ON (B)(6) 2018, PATIENT DID PRIMARY RTHR WITH COMPETITOR FULLY CEMENTED IMPLANTS. ON (B)(6) 2018, HIP WAS DISLOCATED 1ST TIME. ON (B)(6) 2018, CLOSED MANIPULATIVE REDUCTION (CMR) WAS DONE. HIP REDUCED. ON (B)(6) 2018, HIP WAS DISLOCATED 2ND TIME. SUSPECTED REASON WAS STEM IS RETROVERTED. ON (B)(6) 2018, 1ST HIP REVISION WAS DONE USING STRYKER IMPLANT. ON (B)(6) 2025, STEM WAS FOUND BROKEN INSIDE CANAL WHEN PATIENT WAS SENT INTO A&E. ON (B)(6) 2025, PATIENT WAS REFERRED TO A SURGEON AND I WAS INFORMED ABOUT THE 2ND REVISION ON (B)(6) 2025. SHELL AND LINER REMAINED (TRIDENT 1 PSL 50MM & 36D X3 LINER). REMOVED BROKEN STEM AND CLEARED ALL CEMENT, PUT IN CEMENTED EXETER 37.5 N1-150MM STEM AND 36+0MM DELTA HEAD. CLINICAL ASSESSMENT LEG LENGTH AND STABILITY ARE BOTH GOOD.

  Patient problems: Insufficient Information

  MAUDE report 21535306 ↗
• InjuryJan 8, 2024Fracture; Fracture

  THE FOLLOWING WAS REPORTED: PRIMARY SURGERY DATE IS (B)(6) 2022. IN (B)(6) 2023, THE PATIENT FELL, BUT HAD NO PROBLEM WALKING. BUT, ON (B)(6) 2023. THE PATIENT CAME THE HOSPITAL WITH PAIN IN THE RIGHT HIP. REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, FOR A SUSPECTED PERI-STEM FRACTURE. AND THE STEM WAS ALSO, FOUND TO BE BROKEN.

  Patient problems: Bone Fracture(s); Fall; Pain

  MAUDE report 18468677 ↗
• InjuryJul 14, 2023Loss of Osseointegration; Device Dislodged or Dislocated; Loss of Osseointegration; Device Dislodged or Dislocated

  REVISION THR. ACCORDING TO THE COMPLAINANT THE EXETER WAS EXPLANTED FROM THE PATIENT. PATIENT COMPLAINT OF PAIN AND LOOSING OF IMPLANT.

  Patient problems: Inadequate Osseointegration; Joint Dislocation; Pain

  MAUDE report 17330150 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TRIDENT II STUDY, POSTOPERATIVELY FRACTURE AROUND THE STEM WAS REPORTED. ADDITIONAL INFORMATION: ORIF WAS PERFORMED FOR THE FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 16985636 ↗
• InjurySep 2, 2022Fracture; Fracture

  PATIENT FALLS AND GOES TO THE HOSPITAL. X-RAYS REVEALED A BROKEN STEM.

  Patient problems: Fall

  MAUDE report 15346714 ↗
• InjuryMay 20, 2021Fracture; Fracture

  THE SURGEON REPORTED THAT HE OPERATED HIP PATIENT ON (B)(6) 2018 WITH STRYKER HIP SYSTEM AND AFTER FOLLOW-UP HE FOUND STEM BROKEN WHEN HE DID XRAY ON (B)(6) 2021. NOW SURGEON ASKING THE REASON FOR BREAKAGE AND SUPPORT FOR PATIENT. THE IMPLANTS ARE NOT AVAILABLE FOR RETURN DUE TO STILL BEING IN THE PATIENT. PATIENT HAS NOT BEEN REVISED AS OF THE TIME OF REPORT.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 11854016 ↗
• InjuryApr 13, 2021Component Incompatible; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Component Incompatible; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

  A VERY SMALL INTELLECTUALLY AND DEVELOPMENTALLY DISABLED PATIENT WHO ORIGINALLY PRESENTED WITH A FRACTURED FEMUR THAT WAS OPERATED ON ((B)(6) 2021) RECEIVING A THR. DUE TO THE VERY SMALL NATURE OF THIS PATIENT AND CHALLENGING ANATOMY THE PATIENT PRESENTED WITH A DISLOCATED THR A WEEK LATER AND WAS REVISED AGAIN ON THE (B)(6) 2021. THE FEMORAL CANAL WAS SO LIMITING IN SIZE THAT THE LARGEST STEM THAT COULD BE PLACED WITHOUT COMPROMISING THE PATIENTS BONE WAS AN EXETER 33 OFFSET, AND REQUIRED A 22.2MM +8MM HEAD WHICH IS OFF LABEL AND WAS MADE CLEAR TO THE SURGEON WHICH HE ACCEPTED TAKING THE RISK. UPDATE 22 MARCH 2021: THE ORIGINAL EXETER 30MM STEM REVISED AS THE OFFSET WAS NOT ENOUGH. THE 33MM EXETER STEM WAS USED WHEN REVISED AND THE CUP (A COMPETITOR) WAS RE IMPLANTED. THAT THE SURGEON HAD TO USE A +8MM HEAD WHICH IS OFF LABEL USE ON THE 33MM EXETER STEM BUT WAS THE ONLY HEAD OPTION TO BE STABLE ENOUGH.

  Patient problems: Ambulation or Postural Difficulties; Congenital Defect/Deformity; Failure of Implant

  MAUDE report 11657703 ↗
• InjuryAug 3, 2020Fracture; Fracture

  EXETER V40 STEM GOT BROKEN. PATEINT HAS UNDERGONE SURGERY ON (B)(6) 2017 AND STRYKER EXETER STEM GOT BROKEN. PATIENT UNDERGONE REVISION SURGERY WITH STRYKER NEW EXETER STEM.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 10355042 ↗
• InjuryJul 30, 2019Break; Break

  IT WAS REPORTED THAT PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2013. THE PATIENT COMPLAINED OF PAIN AND X-RAY SHOWED THE RIGHT SIDE EXETER STEM WAS BROKEN IN A PATIENT BODY. THE BROKEN STEM WAS EXPLANTED FROM THE CEMENT MANTLE AND REVISED SUCCESSFULLY.

  Patient problems: Injury; Pain

  MAUDE report 8841779 ↗
• InjuryAug 30, 2018Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT PATIENT GOT THR IN 2012. THE PATIENT VISITED THE HOSPITAL WITH EXPERIENCING HIP PAIN. ON X-RAY, THE STEM BREAKAGE WAS FOUND.

  Patient problems: Injury; Pain

  MAUDE report 7834977 ↗