EXETER 0580-1-352Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04546540153241), received between Jul 31, 2017 and Sep 24, 2026 — classified as 21 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. Aug 28, 2025Open, Classified

   a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.

   Z-2640-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Loss of Osseointegration

  Patient problems: Inadequate Osseointegration

  MAUDE report 50892361 ↗
• InjuryMar 17, 2026Migration

  THE FOLLOWING INFORMATION WAS PROVIDED: A TOTAL HIP REPLACEMENT WAS DONE 0N (B)(6) 2023. THE STEM HAS SUBSIDED. REVISED.

  Patient problems: Insufficient Information

  MAUDE report 24616800 ↗
• InjurySep 15, 2025Loss of Osseointegration; Failure to Advance; Loss of Osseointegration; Failure to Advance

  NO NEW INFORMATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059245 ↗
• InjuryMar 24, 2025Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON ADVISED PT EXPERIENCING LEG LENGTH DISCREPANCY, NEEDS REVISION OF EXETER STEM. PRIMARY SURGERY PERFORMED; REVISION PLANNED. 1 MONTH TILL PLANNED SURGERY DATE.

  Patient problems: Unequal Limb Length

  MAUDE report 21676630 ↗
• InjuryJul 31, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENTS X-RAY SHOWED A FRACTURED STEM. PATIENT PRESENTED TO EMERGENCY (B)(6)2024. IT WAS FURTHER REPORTED THAT "PATIENT REQUIRED REVISION HIP ARTHROPLASTY WITH FEMORAL OSTEOTOMY, CEMENT REMOVAL. POLY LINER CHANGED AND NEW RESTORATION MODULAR STEM IMPLANTATION WITH 5 DALL MILES CABLES."

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 19871952 ↗
• InjuryJun 6, 2023Fracture; Fracture

  THE PRIMARY SURGERY DATE FOR BOTH WAS (B)(6) 2011. THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2023 WITH PAIN ON THE RIGHT THIGH. THE BROKEN STEM WAS FOUND ON X-RAY. THE REVISION SURGERY FOR THE RIGHT WAS ON (B)(6) 2023.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 17069110 ↗
• InjuryMay 23, 2023Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  AS PER REP: "IT WAS A REVISION HIP. WE REMOVED AN EXETER STEM WHICH WAS A 37.5 NO.0" UPDATE: PATIENT WAS REVISED DUE TO DISLOCATION BETWEEN STEM AND HEAD.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 16982493 ↗
• InjuryJan 21, 2023Fracture; Fracture

  EXETER STEM FRACTURED. REVISION SURGERY NEEDED TO REPLACE FRACTURED STEM.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 16221506 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, "REVISED AN EXETER/MITCH COMBINATION THIS MORNING". THIS PI IS FOR THE RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 15707304 ↗
• InjurySep 22, 2022Fracture; Fracture

  EXETER STEM TRUNNION BREAKAGE - PATIENT WALKING AT WORK AND INSTANTLY COLLAPSED. PATIENT PRESENTED TO HOSPITAL. REPORTED BY REGISTRAR/SURGEON TO TERRITORY MANAGER. REVISION SURGERY ON (B)(6) 2022. NO SIGNS OF METALOSIS IN TISSUES UPON REVISION. (INITIAL PROCEDURE ON (B)(6) 2016) RIGHT SIDE.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15462528 ↗
• InjuryApr 5, 2022Fracture; Fracture

  IT HAS BEEN REPORTED "PATIENT OPERATED WITH CEMENTED BIPOLAR/HEMIARTHROPLASTY DONE IN (B)(6) 2015 HAS COME BACK TODAY WITH BROKEN NECK OF THE CEMENTED FEMORAL STEM. EXETER STEM LIKELY AS PER THE SURGEON. BROKEN NECK OF FEMORAL CEMENTED STEM CAUSING HIP PAIN, LEADING TO IMPLANT FAILURE AND THEREBY NOW THE PATIENT IS BEEN POSTED FOR REVISION THR FOR EXPLANTING THE BROKEN STEM AND REVISING THE FEMUR. INDEX SURGERY DONE IN 2015. THE STEM IS LIKELY TO BE EXETER CEMENTED FEMORAL STEM SYSTEM AS PER THE OPERATING SURGEON. MORE DETAILS LIKE IMPLANT LABELS, DISCHARGE SUMMARY AND PATIENT DETAILS FROM INDEX SURGERY HAVE BEEN REQUESTED FOR."

  Patient problems: Pain

  MAUDE report 14018060 ↗
• InjuryDec 10, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH STEM FX AND PAIN IN THE RIGHT HIP. THE XRAYS SHOWED FX AND THE PATIENT REQUIRED A REVISION SURGERY TO A RESTORATION MODULAR.

  Patient problems: Pain

  MAUDE report 12974859 ↗
• InjuryOct 12, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH STEM FX AND PAIN. XRAY SHOWS FX. PATIENT IS MALE 77YEARS OLD LEFT SIDE WEIGHT 108KG. IT WAS REPORTED THAT A REVISION WAS REQUIRED.

  Patient problems: Pain

  MAUDE report 12618838 ↗
• InjuryAug 31, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANTED EXETER STEM HAD BROKEN. REVISION SURGERY WAS COMPLETED AND THE EXETER WAS REMOVED AND REPLACED WITH A REST MOD. IT WAS FURTHER REPORTED THAT THE BROKEN STEM WAS DISCOVERED FOLLOWING X RAYS AND THAT THE INITIAL SIGNS OF THE BROKEN STEM WERE NOTICED WHEN THE PATIENT FELT A CLICK WHILE WALKING THEN LATER HAD DIFFICULTY AMBULATING AND GETTING OUT OF BED AND REQUIRED USE OF WALKER.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Injury

  MAUDE report 10473522 ↗
• InjuryNov 21, 2019Break; Fracture; Break; Fracture

  BROKEN EXTER STEM. REVISED STEM TO A CEMENT IN CEMENT STEM.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 9353392 ↗
• InjurySep 27, 2019Break; Break

  THE PATIENT UNDERWENT A PRIMARY HIP SURGERY ON (B)(6) 2017. AFTER PERFORMING A NORMAL RECOVERY, ON (B)(6) HE WENT TO THE DOCTOR BECAUSE HE HAD PAIN. THE DOCTOR WHEN CHECKING AND AFTER SEEING THE PLAQUE, CONFIRMS THAT THE PROSTHESIS PLACED IS BROKEN. AFTER A TELEPHONE COMMUNICATION WITH DR, HE SAYS THAT THE PATIENT SUFFERED A FALL, IT IS NOT KNOWN IF THIS IS THE ROOT CAUSE. THE SURGEON OF THE SECOND CONSULTATION IS NOT THE SAME SURGEON OF THE PRIMARY SURGERY.

  Patient problems: Fall; Pain

  MAUDE report 9128931 ↗
• InjuryMay 15, 2019Break; Break

  EXETER STEM 37.5 N0 WAS IMPLANTED IN (B)(6) 2012 INTO PATIENT . IT WAS DISCOVERED AS BROKEN WITH THE X-RAY ATTACHED. REVISION SURGERY WILL BE SCHEDULED LATER ON. UPDATE: PATIENT DID NOT SUFFER ANY TRAUMA. LEFT SIDE.

  Patient problems: Injury

  MAUDE report 8612155 ↗
• InjuryApr 16, 2019Fracture; Fracture

  REVISION RIGHT TOTAL HIP REPLACEMENT. REMOVAL OF BROKEN EXETER STEM. REVISED TO RESTORATION MODULAR. "SUDDEN INCREASE IN PAIN 3 WEEKS AGO SIMPLY WALKING, NO FALL."

  Patient problems: Injury

  MAUDE report 8518203 ↗
• InjuryJan 28, 2019Crack; Fracture; Crack; Fracture

  A DR REVISED AN EXETER HIP STEM AS IT APPEARED TO HAVE FRACTURED WHEN VIEWED ON X-RAY. THE PATIENT SAID SHE WAS WALKING DOWNSTAIRS A FEW DAYS PRIOR TO (B)(6) AND SHE MISSED A STEP AND LANDED HEAVILY AND FELT SOMETHING CRACK IN HER LEFT LEG. THE SURGEON REMOVED THE EXETER STEM AND HEAD AND REPLACED IT WITH A RESTORATION MODULAR PROSTHESIS. THE SURGEON COMMENTED THAT THE PATIENT HAD A TRIDENT CUP INSITU WITH A CERAMIC LINER.

  Patient problems: Injury

  MAUDE report 8281204 ↗
• InjuryAug 14, 2018Break; Fracture; Break; Fracture

  PATIENT HAD A TOTAL BILATERAL HIP ARTHROPLASTY (SAME LOT BOTH SIDES) IN 2013. THE LEFT SIDE FRACTURED IN DECEMBER 2016 AND A REVISION SURGERY WAS REQUIRED. DOCTOR REPORTS THAT PATIENT IS OBESE AND HAS A HISTORY OF "STUMBLING". THE CONTRALATERAL STEM REMAINS ASYMPTOMATIC UNTIL THE LAST FOLLOW-UP. PATIENT SUBMITTED BROKEN PIECE FOR ANALYSIS IN THIRD-PARTY LABORATORY .

  Patient problems: Injury

  MAUDE report 7780592 ↗
• InjuryJun 19, 2018Degraded; Material Deformation; Degraded; Material Deformation

  THE SURGEON REVISED A FAILED EXETER / CONTEMPORARY CUP. THE SURGEON REPORTED A SHATTERED FEMORAL HEAD AND A VERY WORN FEMORAL TRUNNION. UPDATE- ONE YEAR FOLLOW UP X-RAY SHOWED A CERAMIC HEAD FRACTURE.

  Patient problems: Injury

  MAUDE report 7615712 ↗
• MalfunctionNov 2, 2017Fitting Problem; Fitting Problem

  THE CUSTOMER REPORTED THAT THE SPIGOT OF THE EXETER HIP WOULD NOT FIT ONTO THE EXETER INTRODUCER. THE SURGEON REMOVED THE PLASTIC PART AND PROCEEDED TO INTRODUCE THE EXETER STEM BY HAND. THERE WAS NO DELAY TO SURGERY BUT IT DID MEAN THAT THE STANDARD INSTRUMENTATION COULD NOT BE USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6996187 ↗
• MalfunctionJul 31, 2017Sticking; Packaging Problem; Sticking; Packaging Problem

  THE CUSTOMER REPORTED THAT, AS THE SCRUB NURSE PEELED BACK THE TOP FILM LAYER OF THE EXETER STEM PACKAGE, THE STERILE PACKAGING LAYER UNDERNEATH WAS BONDED TO THE TOP LAYER. THE SURGEON CHOSE NOT TO USE THIS IMPLANT IN CASE STERILITY HAD BEEN BREACHED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6755404 ↗