EXETER 0580-1-044Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04546540509048), received between Apr 13, 2018 and Feb 25, 2026 — classified as 20 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (13 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Dec 30, 2021Terminated

   There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.

   Z-0651-2022 · Root cause: Labeling mix-ups · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: "BROKEN METAL STEM IN 20-YEAR-OLD HIP PROSTHESIS".

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 24442524 ↗
• InjuryDec 15, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: Pain

  MAUDE report 23802373 ↗
• InjuryApr 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD A REVISION DUE TO DISLOCATION AND SUSPECTED HEAD DISSOCIATION.

  Patient problems: Joint Dislocation

  MAUDE report 21748902 ↗
• InjuryMar 25, 2025Fracture; Fracture

  POSTOPERATIVELY, THE STEM WAS BROKE OFF. THE FIRST SURGERY IN THIS CASE WAS PERFORMED ON (B)(6) 2014 AND THE FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. THE REASON FOR THE REVISION WAS PROBABLY STEM LOOSENING BUT CANNOT BE IDENTIFIED. THE PRODUCT IN QUESTION IS A STEM INSERTED INTO THE PATIENT AT THE REVISION SURGERY.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 21688599 ↗
• InjuryMar 13, 2025Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  NO NEW INFORMATION.

  Patient problems: Joint Dislocation

  MAUDE report 21593122 ↗
• InjuryDec 19, 2024Fracture; Fracture

  EXETER STEM FRACTURED INSIDE PATIENT REQUIRING REMOVAL AND REPLACEMENT WITH ANOTHER STEM. THE DATE OF STEM FRACTURED INSIDE PATIENT IS UNKNOWN AND THE MECHANISM OF FRACTURE IS ALSO UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 20979367 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION HIP REPLACEMENT DUE TO GREATER TROCHANTER FRACTURE. STEM THAT WAS IN WAS UNSTABLE DUE TO FRACTURE AND WAS REPLACED, ALONG WITH HEAD AND LINER. UPDATE 17/10: FIRST REVISION (B)(6) 2023 DUE TO PERIPROSTHETIC FRACTURE, SECOND REVISION (B)(6) 2023 DUE TO GREATER TROCHANTER FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 18095169 ↗
• InjuryAug 21, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: "FRACTURE SHORT STEM EXETER 4 YEAR POST-REVISION - ATRAUMATIC".

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s)

  MAUDE report 17587476 ↗
• InjuryMar 30, 2023Fracture; Fracture

  LETTER RECEIVED FROM SOLICITOR - "EXETER CEMENTED HIP STEP - OUR CLIENT SUFFERED A FRACTURE OF HIS EXETER HIP STEM AND THIS WAS SUBSEQUENTLY REPAIRED IN (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 16642331 ↗
• InjuryMar 29, 2023Fracture; Fracture

  SOLICITORS LETTER RECEIVED REGARDING A REVISION THAT WAS REQUIRED OF A TOTAL HIP REPLACEMENT." A FRACTURE OF THE STEM OF THE FEMORAL PROSTHESIS."

  Patient problems: Insufficient Information

  MAUDE report 16636169 ↗
• InjuryJul 22, 2022Fracture; Fracture

  PATIENT WAS SEEN ON (B)(6) 2022 COMPLAINING OF PAIN AROUND LEFT HIP. BROKEN STEM IDENTIFIED. ON (B)(6) 2022- REVISION - ETO AND REMOVAL OF BROKEN STEM AND CEMENT - REVISED TO RESTORATION STEM. ALSO, REMOVAL OF POLY LINER FROM TRITANIUM SHELL WHICH WAS REPLACED BY MDM LINER. LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 15083831 ↗
• InjuryDec 21, 2020Fracture; Unstable; Fracture; Unstable

  STRYKER REP REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH PAIN AND INSTABILITY IN RIGHT HIP ¿ X RAY SHOWS BROKEN EXETER HIP STEM ¿ HIP HAS BEEN NOW REVISED TO NON CEMENTED OPTION.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 11046557 ↗
• InjuryAug 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  HE HAD A CEMENT MANTLE FRACTURE PROXIMAL RIGHT HIP. HAD A TRAUMATIC FALL (B)(6) 2019 - LOOSE, OTHER HIP REQUIRED DHS (NON-STRYKER PRODUCTS INVOLVED ON OPPOSITE HIP). PROXIMAL FEMORAL OSTEOLYSIS. NOTICED ON X-RAY UPON NOTICING PAIN AND AFTER THEIR TRAUMA. UPDATE: 27 JULY 2019: SURGEON WAS REVISING DUE TO SIGNS OF OSTEOLYSIS. NOTICED CEMENT MANTLE FRACTURE DURING PROCEDURE.

  Patient problems: Injury

  MAUDE report 10434923 ↗
• InjuryJul 21, 2020Break; Break

  THE SURGEON REVISED THE PATIENT'S TOTAL HIP PROSTHESIS DUE TO THE BREAK OF THE EXETER NAIL IMPLANTED IN THE PATIENT.

  Patient problems: Injury; Insufficient Information

  MAUDE report 10305527 ↗
• InjuryFeb 26, 2020Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE EXETER STEM WAS REVISED. **UPDATE** REASON FOR REVISION: BROKEN STEM WITH RESULTANT PERIPROSTHETIC FEMORAL FRACTURE- SEVERE PAIN AND UNABLE TO WEIGHT BEAR.

  Patient problems: Bone Fracture(s); Extraskeletal ossification; Hip Fracture; Injury

  MAUDE report 9756558 ↗
• InjuryJul 30, 2019Break; Break

  IT WAS REPORTED THAT THE EXETER STEM FRACTURED DISTALLY AND WAS REVISED.

  Patient problems: Injury

  MAUDE report 8840904 ↗
• InjuryJul 16, 2019Break; Fracture; Break; Fracture

  BROKEN EXETER STEM REVISED USING RESTORATION MODULAR COMPONENTS.

  Patient problems: Injury

  MAUDE report 8795080 ↗
• InjuryJan 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY OF LEFT HIP WAS DONE AT (B)(6) DUE TO INFECTION. INFORMATION OF THE PRIMARY IMPLANT WAS NOT RECEIVED NOW. WHEN THE REVISION SURGERY OF RIGHT HIP, THE V40 HEAD +10MM (6260-9-336) WAS IMPLANTED TO "EXCETER" STEM (0580-1-044) BECAUSE THE STEM WAS IMPLANTED DEEPER THAN PLANNED. THE SR EXPLAINED TO THE SURGEON THAT IT WAS USE OUTSIDE OF INDICATION. BUT THE STEM WAS REVISE AND THE OPERATION WAS FINISHED. THIS PI IS FOR REVISION OF LEFT HIP ON (B)(6) DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8245314 ↗
• InjuryJan 2, 2019Break; Fracture; Break; Fracture

  PATIENT WHO TREATED BHA IN 2012 (OTHER COMPANY IMPLANT) WAS INFECTED AND REVISED IN EXETER FOR THE FIRST TIME IN 2012. CONFIRMING BREAKAGE OF THE STEM BY FOLLOW UP ON (B)(6) 2018. NEXT YEAR IN 2019 WE WILL REMOVE THE BROKEN STEM AND IT WILL BE REPLACED AGAIN. (B)(6) 2018 - STEM BROKE IN THE MIDDLE.

  Patient problems: Injury

  MAUDE report 8209446 ↗
• InjuryOct 18, 2018Break; Crack; Fracture; Break; Crack; Fracture

  AN EXETER 44 #00 CEMENT IN CEMENT REVISION STEM HAS FRACTURED WITHIN THE CEMENT MANTLE APPROX 4 YEAR¿S AFTER REVISION SURGERY. THERE WAS NO PRIOR FALL OR TRAUMA.

  Patient problems: Injury

  MAUDE report 7981397 ↗
• MalfunctionJul 9, 2018Packaging Problem; Packaging Problem

  SALES REP RECEIVED INFORMATION FROM THE HOSPITAL THAT IN THE BOX OF ITEM REF 05801044. THERE WERE 2 TIMES CENTRALIZER WITH WINGS AND THE ONE WITHOUT WINGS WAS MISSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7669683 ↗
• MalfunctionApr 13, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE SURGEON REPORTED THAT AS HE WAS UNDERTAKING A CEMENT IN CEMENT REVISION OF AN EXETER STEM ((B)(4)) AND HE ATTEMPTED TO PUT A SHORT STEM EXETER ((B)(4)) INTO THE FEMUR AFTER REMOVING THE ORIGINAL STEM. THE SURGEON REPORTED THAT THE NEW STEM ((B)(4)) WOULD NOT FIT THE HOLE LEFT AFTER EXPLANTATION OF THE PRIMARY DEVICE. THE STEM WAS REMOVED DUE TO A POOR FIT USING A BROACH HANDLE AND COULD THEN NO LONGER BE USED FOR THIS PATIENT. THE SURGEON REAMED (AND ALSO USED OSCAR TO REMOVE SOME ADDITIONAL CEMENT MANTLE) AND THEN ATTEMPTED IMPLANTATION WITH A SECOND SHORT STEM EXETER ((B)(4)). THIS WAS SUCCESSFUL BUT THE SURGEON REPORTED THAT THERE WERE DIFFERENCES DISTALLY BETWEEN THE OLD AND TWO NEW STEMS. THE SURGEON ALSO NOTED THAT WHEN HE USED A TRIAL STEM ((B)(4)) THIS WAS ALSO A TIGHT FIT COMPARED TO THE ORIGINAL. THE CASE WAS COMPLETED SUCCESSFULLY. PRIMARY SURGERY WAS DONE IN 2007. REP HAS CONFIRMED THAT SURGICAL DELAY WAS 1-1.5HOURS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7429544 ↗