EXETER 0580-1-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04546540153364), received between Sep 10, 2018 and Feb 19, 2026 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE JR IMPLANTS. IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PROXIMAL FEMORAL FRACTURE REP CONFIRMED FRACTURE WAS PROXIMAL TO AXSOS 3 CORTEX SCREWS AND THAT NO SCREWS WERE DAMAGED. ALL IMPLANTS WERE REMOVED. STRYKER ACETABULAR COMPONENTS AND COMPETITOR FEMORAL COMPONENTS WERE IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 24390636 ↗
• InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT REPORTED A PRIMARY STRYKER THA WAS IMPLANTED IN HER LEFT HIP (B)(6) 2022 1 DAY POST-OP, PATIENT NOTICED A LIMB LENGTH DISCREPANCY OF APPROXIMATELY AN ADDITIONAL .75" ON HER OPERATIVE SIDE (PATIENT IS 65" STANDING ON HER RIGHT FOOT, 65.75" STANDING ON HER LEFT FOOT). INDEX SURGEON PROPOSED TO IMPLANT A THA ON THE CONTRALATERAL SIDE TO MATCH LIMB LENGTHS. AFTER SEEKING A SECOND OPINION, A REVISION OF THE HIP IS SCHEDULED (B)(6) 2022. REVISING SURGEON REPORTED TO THE PATIENT THAT THE IMPLANTS WERE TOO LARGE FOR THE PATIENT'S ANATOMY. PATIENT IS INQUIRING IF THERE HAVE BEEN OTHER REPORTS OF LIMB LENGTH DISCREPANCY REPORTED WITH THE INDEX SURGEON OR WITH HER IMPLANTS. UPDATE (B)(6) 2022 (B)(6): CLARIFICATION FROM PATIENT: "I'M NOT SURE HE [REVISING SURGEON] ACTUALLY SAID IT WAS TOO BIG FOR MY ANATOMY, MORE THAT THE ANGLE WAS WRONG. WE DIDN'T REALLY UNDERSTAND. ON MY LAST POST OP VISIT WITH THE ORIGINAL DOCTOR HE CHANGED HIS PLAN FROM DOING MY RIGHT HIP TO HAVING PELVIC OBLIQUITY PHYSICAL THERAPY FOR MY LEFT AND GETTING A SPECIAL SHOE MADE."

  Patient problems: Ambulation or Postural Difficulties; Unequal Limb Length

  MAUDE report 15223184 ↗
• InjuryMay 20, 2022Fracture; Fracture

  THE FOLLOWING WAS REPORTED: REVISION TOTAL HIP REPLACEMENT. BROKEN EXETER STEM REMOVED DURING PROCEDURE.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14460595 ↗
• InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION CASE.

  Patient problems: Insufficient Information

  MAUDE report 12726719 ↗
• InjuryOct 4, 2021Fitting Problem; Insufficient Device Problem Information; Fitting Problem; Insufficient Device Problem Information

  DURING A THA REVISION, THE SURGEON REMOVED A 50 NO.1 CEMENTED STEM AND ATTEMPTED TO REPLACE THE STEM WITH ANOTHER 50 NO.1 ¿ HE INDICATED THE STEM WAS WIDER AT THE BOTTOM COMPARED TO THE PREVIOUS STEM AND THEREFORE COULD NOT USE IT- THIS RESULTED IN A DELAY TO THE CASE AND ULTIMATELY A SMALLER STEM BEING INSERTED. (B)(6) 2021 UPDATE: TWO STEMS WERE TRIED DURING THE CASE AND BOTH WERE REPORTED TO HAVE FIT ISSUES SURGICAL DELAY WAS ESTIMATED AT 120 MINUTES WHILE ATTEMPTING TO REMOVE CEMENT MANTLE AND PLACE SUITABLE STEM IN ADDITION, THE PATIENT WAS GIVEN (B)(4) UNITS OF RED BLOOD CELLS INTRA-OPERATIVELY AS RESULT OF BLOOD LOSS THROUGHOUT THE CASE

  Patient problems: Insufficient Information

  MAUDE report 12568076 ↗
• InjuryOct 4, 2021Fitting Problem; Insufficient Device Problem Information; Fitting Problem; Insufficient Device Problem Information

  DURING A THA REVISION, THE SURGEON REMOVED A 50 NO.1 CEMENTED STEM AND ATTEMPTED TO REPLACE THE STEM WITH ANOTHER 50 NO.1 ¿ HE INDICATED THE STEM WAS WIDER AT THE BOTTOM COMPARED TO THE PREVIOUS STEM AND THEREFORE COULD NOT USE IT- THIS RESULTED IN A DELAY TO THE CASE AND ULTIMATELY A SMALLER STEM BEING INSERTED. 07SEP21: UPDATE: TWO STEMS WERE TRIED DURING THE CASE AND BOTH WERE REPORTED TO HAVE FIT ISSUES. SURGICAL DELAY WAS ESTIMATED AT 120 MINUTES WHILE ATTEMPTING TO REMOVE CEMENT MANTLE AND PLACE SUITABLE STEM. IN ADDITION, THE PATIENT WAS GIVEN 4 X UNITS OF RED BLOOD CELLS INTRA-OPERATIVELY AS RESULT OF BLOOD LOSS THROUGHOUT THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 12568075 ↗
• InjuryJun 1, 2021Break; Fracture; Break; Fracture

  ON THE (B)(6)THE PATIENT WAS COOKING IN THE KITCHEN. THE PATIENT TURNED AROUND AND DROPPED THROUGH HIS LEG OR SLIPPED. PATIENT IMMEDIATELY WASN¿T ABLE ANYMORE TO LOAD THE LEFT LEG. PATIENT WAS BROUGHT IN WITH THE AMBULANCE. PATIENT HAS A BROKEN EXETER STEM.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 11912619 ↗
• InjuryOct 5, 2020Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  REVISION SURGERY ON STRYKER IMPLANTS. REPLACED WITH STRYKER STEM AND FEMORAL HEAD AND DEPUY CUP AND INSERT (B)(6) 2020. PATIENT COMPLAINT OF PAIN AND SQUEAK / CLUNKINESS. SIGNS OF TRUNIONOSIS AND IMPINGEMENT NOTED BY SURGEON. STRIPE WEAR ON CERAMIC HEAD. LINER RIM DAMAGED BY WEAR FROM STEM REVISION ON PREVIOUS PRIMARY SURGERY.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 10631105 ↗
• InjuryJun 16, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  RIGHT FEMORAL PERIPROSTHETIC FRACTURE. NOTICED AFTER SURGEON REVIEW OF X-RAY AFTER PT FELL OVER.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 10157599 ↗
• InjuryMay 21, 2019Fracture; Fracture

  THE CUSTOMER REPORTED THAT A PATIENT WHO HAD BEEN IMPLANTED WITH AN EXETER STEM IN 2009 DURING A THR HAS UNDER GONE A REVISION. THE PATIENT TRIPPED WITHOUT FALLING IN (B)(6) 2019 AND HEARD A SNAP. THE PATIENT PRESENTED TO THE EMERGENCY DEPT AND THE X-RAY SHOWED A FRACTURED STEM. THE CUSTOMER FURTHER REPORTED THAT THE STEM HAD FRACTURED AT THE NECK

  Patient problems: Injury

  MAUDE report 8629253 ↗
• MalfunctionMay 20, 2019Break; Break

  DURING COMMUNICATION, THE THEATRE MANAGER REPORTED THAT THE SURGEON COMMENTED THAT SIMILAR EVENT MIGHT HAVE HAPPENED BEFORE TO THEIR COLLEAGUES. THE EVENT WAS THAT THE PLASTIC CENTRALIZER FITTED TO STEM BUCKLED. UPDATE 29/APRIL/2019 (B)(6): AS REPORTED BY HOSPITAL STAFF, A SURGICAL DELAY OF APPROXIMATELY 10 MINUTES WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8624523 ↗
• MalfunctionMay 6, 2019Break; Break

  CUSTOMER REPORTED TO (B)(6) THAT THE PLASTIC CENTRALISER FITTED TO STEM BUCKLED, SO WOULD NOT FIT THE STEM INTRODUCER. AN ALTERNATIVE WAS FOUND TO COMPLETE THE CASE. UPDATE: DELAY OF SURGERY 10 MIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8583615 ↗
• MalfunctionSep 10, 2018Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT THEY OPENED AN EXETER STEM AND NOTICED THAT THE LUG HAD BROKEN OFF THE SPIGGOT PROTECTOR. A NEW IMPLANT WAS USED TO COMPLETE THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7861833 ↗