EXETER 0580-1-441Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04546540153302), received between Feb 7, 2014 and May 6, 2026 — classified as 1 death, 28 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: "PATIENT WITH AN EXETER STEM IMPLANTED IN LEFT HIP SINCE 10 YEARS SUDDENLY FELT PAIN WHEN WALKING INSIDE THE HOUSE AND WAS NOT ABLE TO LIFT HIS LEG. WENT TO THE ER AND WHERE THEY FIND A BROKEN STEM ON THE X-RAY AND HE WAS TAKEN TO OR THE NEXT DAY."

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 25091276 ↗
• InjuryNov 21, 2025Fracture; Fracture

  THE FOLLOWING WAS REPORTED BY THE REP: "AN EXETER STEM WAS REVISED LAST WEEK AS IT HAD SNAPPED AT THE SHOULDER." PATIENT PRESENTED WITH BROKEN IMPLANT AFTER SLIPPING IN/ON THE WAY TO THE BATHROOM. PATIENT WAS REVISED ON (B)(6) 2025.

  Patient problems: Fall

  MAUDE report 23616274 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  REVISION SURGERY FOR EXETER CEMENTED STEM, LINER POLY AND FEMORAL HEAD DUE TO SUBSIDENCE SECONDARY TO GT FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 22305473 ↗
• InjuryMar 4, 2025Fracture; Fracture

  NO NEW INFORMATION

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 21514213 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO FEMORAL PAIN. INTRA-OPERATIVELY, NOTHING WAS OBSERVED TO BE LOOSE, BROKEN, OR WORN. AN EXETER STEM, HEAD, ADM/ MDM POLY INSERT AND MDM METAL LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, HEAD, ADM/ MDM POLY INSERT AND MDM METAL LINER WITH CABLES. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. CORRECTION: A TRIDENT X3 ELEVATED RIM INSERT WAS REVISED INSTEAD OF A ADM/ MDM POLY INSERT AND MDM METAL LINER.

  Patient problems: Pain

  MAUDE report 18451127 ↗
• InjuryDec 7, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  CATASTROPHIC FAILURE OF EXETER STEM USED IN THA. PRIMARY OPERATION 2020 FOR OA. WHEN PATIENT WAS BENDING OVER IN CHAIR, HAD DISCOMFORT IN LEFT HIP. ABLE TO MOBILISE AFTER, WATERING GARDEN, WALKING, SUDDENLY FELT IT 'GIVE WAY'. WOUND HEALED. UPDATE: CLINICIAN REVIEW OF THE PROVIDED X-RAY AND CT SCAN IMAGES INDICATED THAT HEAD NECK DISASSOCIATION AND TRUNNION FRACTURE HAD OCCURRED.

  Patient problems: Ambulation or Postural Difficulties; Discomfort

  MAUDE report 18284672 ↗
• InjuryApr 24, 2023Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO FEMORAL PAIN. A STEM (IMPLANTED (B)(6) 2012), HEAD AND LINER (BOTH IMPLANTED (B)(6) 2014) WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, FEMORAL HEAD, AND ADM/ MDM LINER CONSTRUCT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE (B)(6) 2023 MF: PER OFFICE NOTES RECEIVED DATED (B)(6) 2022: PATIENT IS EXHIBITING "AREAS OF POSTERIOR PROXIMAL FEMORAL OSTEOLYSIS BETWEEN THE MID AND UPPER FEMORAL CEMENT MANTLE" AND AN "IMPINGEMENT PIT OR CYSTIFICATION ALSO NOTED IN THE SUPEROLATERAL ASPECT OF [THE] FEMORAL NECK." ADDITIONALLY, "THE RECENT CAT SCAN SHOWS DRAMATICALLY SIGNIFICANT CORTICAL BONE LOSS OR OSTEOLYSIS DEVELOPING AROUND THE FEMORAL CEMENT MANTLE" AND THE "CORTEX IS BECOMING REMARKABLY THIN IN SOME REGIONS." UPDATE (B)(6) 2023: THE OFFICE NOTES ALSO ALLEGED "UNDERLYING SOFT TISSUE DAMAGE FROM METALLOSIS."

  Patient problems: Metal Related Pathology; Osteolysis; Pain

  MAUDE report 16797225 ↗
• InjuryJan 25, 2023Corroded; Adverse Event Without Identified Device or Use Problem; Corroded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, "THE SURGEON ADVISED THAT HE WAS REVISING AN EXETER/MITCH COMBINATION DUE TO ELEVATED COBALT/CHROMIUM LEVELS IN THE PATIENT."

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 16241035 ↗
• InjuryDec 14, 2022Corroded; Material Erosion; Insufficient Device Problem Information; Corroded; Material Erosion; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION TOOK PLACE: REVISION OF AN EXETER/MITCH COMBINATION DUE TO ELEVATED COBALT/CHROMIUM LEVELS IN THE PATIENT.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 15975819 ↗
• InjuryOct 25, 2022Fracture; Fracture

  BROKEN EXETER STEM. CERAMIC HEAD WAS ALSO REVISED.

  Patient problems: Insufficient Information

  MAUDE report 15665070 ↗
• InjuryOct 13, 2022Device Contaminated During Manufacture or Shipping; Adverse Event Without Identified Device or Use Problem; Device Contaminated During Manufacture or Shipping; Adverse Event Without Identified Device or Use Problem

  PATIENT ADMITTED FOR REVISION SURGERY, INDICATED DUE TO PERIPROSTHETIC INFECTION. STRYKER DEVICE EXPLANTED, AND COMPETITOR ITEMS IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 15593205 ↗
• InjuryJun 6, 2022Fracture; Fracture

  IT HAS BEEN REPORTED BY THE DISTRIBUTOR THAT "THE PATIENT'S STEM BROKE AT TRUNNION. PATIENT DIDN'T FALL. PATIENT HAS REQUESTED AN INDEPENDENT ANALYSIS OF THE STEM. AS SUCH THE STEM WON'T BE AVAILABLE TO BE RETURNED".

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14609130 ↗
• InjuryMar 23, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: THE PATIENT HAD AN EXETER/ MITCH LEFT THR REVISION.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 13860835 ↗
• InjurySep 24, 2021Corroded; Adverse Event Without Identified Device or Use Problem; Corroded; Adverse Event Without Identified Device or Use Problem

  REVISION OPERATION REQUIRED TO CORRECT STRYKER CONSTRAINED LINER IMPINGEMENT WHICH HAD LEAD TO EXCESSIVE PLASTIC WEAR AND THE LINER'S LOCKING RING BREAKING INSITU. UPDATE 23/SEPTEMBER/2021 WG: AS REPORTED IN THE (B)(6) 2021 OPERATION REPORT: "...EVIDENCE OF PROSTHETIC IMPINGEMENT WITH BURNISHING OF THE POSTERIOR SUPERIOR PORTION OF THE FEMORAL NECK (REFERRED TO IN THE OP REPORT AS AN 'EXISTING EXETER STEM")¿THE CONSTRAINED RING WAS BROKEN AND A PORTION OF THE ACETABULAR RIM WAS FRACTURED..." BASED ON OP REPORTS AND IMPLANT LOT CODE INFORMATION, THE PATIENT HAD A SPACER REVISION IN (B)(6) 2014 (PI (B)(4), CONFIRMED VIA OP REPORT). AT THAT TIME, AN EXETER CONTEMPORARY SHELL, STAINLESS STEEL HEAD, AND EXETER STEM WERE PLACED. SOME TIME BETWEEN (B)(6) 2014 AND (B)(6) 2017, SOME OR ALL OF THOSE IMPLANTS WERE REMOVED AND A CONSTRAINED LINER AND COCR FEMORAL HEAD WERE IMPLANTED (NO RECORD PROVIDED FOR THIS SURGERY, BUT THE REVISED HEAD AND LINER WERE NOT MENTIONED IN THE (B)(6) 2014 SURGERY, AND THE CONSTRAINED LINER WAS MANUFACTURED IN JULY 2014). IN AUGUST OF 2021, THOSE IMPLANTS WERE REVISED. THIS PI IS FOR THE REVISION OF THOSE IMPLANTS, IMPLANTED AT AN UNKNOWN DATE AT THE TIME OF REP

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 12530437 ↗
• InjuryJul 30, 2021Corroded; Insufficient Device Problem Information; Corroded; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE PATIENT WHO HAD PREVIOUSLY BEEN IMPLANTED WITH AN EXETER MITCH COMBINATION HAS BEEN REVISED. **UPDATE** REVISION LEFT HIP PATIENT HAD VERY HIGH METAL ION LEVELS.

  Patient problems: Metal Related Pathology

  MAUDE report 12252692 ↗
• InjuryJul 27, 2021Fracture; Fracture

  THE CUSTOMER REPORTED THAT THE EXETER STEM WAS REVISED DUE TO A FRACTURED STEM.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 12230030 ↗
• InjuryJul 27, 2021Fracture; Fracture

  STRYKER REP REPORTED A BROKEN EXETER STEM THAT HAS NEEDED TO BE REVISED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12229991 ↗
• InjuryJun 29, 2021Fracture; Fracture

  IT HAS BEEN REPORTED "IMPLANT REVISED DUE TO IMPLANT BREAKAGE. NO TRAUMA, SUDDEN PAIN."

  Patient problems: Pain

  MAUDE report 12084212 ↗
• InjuryDec 7, 2020Break; Break

  IT WAS REPORTED THAT WHILE THE PATIENT WAS GOING FROM A STANDING TO A SITTING POSITION THEY FELT SOMETHING SNAP. IT WAS FURTHER REPORTED THAT AN XRAY REVEALED A BROKEN EXETER STEM AT THE STEM'S NECK/HEAD JUNCTION AND A REVISION SURGERY WAS REQUIRED TO REPLACE THE STEM/HEAD/INSERT.

  Patient problems: Hip Fracture

  MAUDE report 10957875 ↗
• InjuryNov 11, 2020Degraded; Degraded

  THA REVISION WAS PERFORMED DUE TO THE CUP LOOSENING. DURING THE REVISION A NECROTIC TISSUE-LIKE GRANULATION TISSUE FILLING AROUND THE TRUNNION OF THE STEM WAS FOUND, AND WHEN THE HEAD WAS REMOVED, THE ENTIRE TRUNNION LOST ITS LUSTER AND RUST-LIKE SUBSTANCE WAS ADHERED. PLEASE INVESTIGATE THE STATE THE TRUNNION.

  Patient problems: Granuloma; Inadequate Osseointegration

  MAUDE report 10823920 ↗
• InjuryAug 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING A THP REVISION FROM A PRIMARY ACCOLANDE TMZF/TRIDENT TITANIUM IN (B)(6) 2019, THE SURGEON DISCOVERED THAT THE POLYETHYLENE WAS DAMAGED/SCRATCHED WITHOUT NOTICING CORPORA LIBERA. NO DAMAGE NOTICEABLE AT THE OLD V40 HEAD. THE DAMAGED X3 POLYETHYLENE ON THIS SHORT TERM IS CONCERNING THE COSTUMER ABOUT THE QUALITY. REASON FOR REVISION - PERIPROSTHETIC FRACTURE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 10355363 ↗
• InjuryJun 10, 2020Fracture; Fracture

  HIP REVISION AFTER BROKEN STEM (EXETER) DIAGNOSIS.

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain

  MAUDE report 10136870 ↗
• InjuryJan 24, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE NECK OF THE EXETER STEM WAS BROKEN IN SITU, THEREFORE THE IMPLANT WAS EXTRACTED AND REPLACED WITH A NEW EXETER STEM.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 9627856 ↗
• InjuryJan 13, 2020Break; Break

  THE SURGEON REPORTED THAT HE THE PATIENT WHO HAD BEEN IMPLANTED WITH AN EXETER STEM IS BEING REVISED. THE STEM BROKE FOLLOWING A LOW FALL FROM A BED.

  Patient problems: Fall; Injury

  MAUDE report 9583264 ↗
• InjuryDec 26, 2018Crack; Fracture; Crack; Fracture

  STRYKER REP REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON AN EXETER STEM. REVISION DATE (B)(6) 2018.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 8198027 ↗