EXETER 0580-1-372Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540153265), received between Oct 20, 2020 and Sep 19, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2025Degraded; Mechanical Problem; Malposition of Device; Degraded; Mechanical Problem; Malposition of Device

  NO NEW INFORMATION.

  Patient problems: Loss of Range of Motion; Metal Related Pathology

  MAUDE report 23097706 ↗
• InjuryFeb 23, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  BHA WAS PERFORMED FOR A PATIENT WITH RIGHT FEMORAL NECK FRACTURE. WHEN CHECKING THE X-RAY AND CT IMAGES JUST AFTER THE PRIMARY SURGERY, IT WAS CONFIRMED THAT THERE WAS A CEMENT LEAK AND THAT THE BONE HAD FRACTURED. IT APPEARED THAT THE TIP OF THE CENTRALIZER HIT THE BONE AND CAUSED THE FRACTURE. BECAUSE REVISION SURGERY INVOLVES A HIGH BURDEN AND RISK TO THE PATIENT, THE SURGEON DECIDED THAT NO REVISION SURGERY OR OTHER MEDICAL INTERVENTION WILL BE PERFORMED, AND ONLY FOLLOWING UP MONITORING WILL BE PERFORMED. IT WAS ALSO REPORTED THAT THERE WAS A SCENE WHERE THE STEM WAS INSERTED BY HITTING IT WITH AN IMPACTOR AS THE CEMENT WAS ABOUT TO HARDEN, SO IT MAY HAVE AFFECTED THE REPORTED FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 21442648 ↗
• InjuryJun 10, 2024Fracture; Fracture

  IT HAS BEEN REPORTED A PATIENT SUFFERED AN INTERVENTION WHOSE THE EXETER ROD 0580-1-372 BROKE AND WAS REPLACED. THE 1ST IMPLANT (BROKEN ONE) WAS IMPLANTED ON (B)(6) 2021. THE BROKEN PART IS AVAILABLE FOR EVALUATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 19497428 ↗
• InjurySep 2, 2022Fracture; Fracture

  IT HAS BEEN REPORTED "WE RECEIVED INFORMATION ABOUT A BROKEN STRYKER IMPLANT, NAMELY, THE EXETER LEG BROKE IN THE PATIENT. PATIENT FELL ON THE STREET, AFTER WHICH A FRACTURE OCCURRED (EXETER LEG BROKE). THE PATIENT TURNED HIMSELF TO THE CLINIC, AS THE PRIMARY OPERATION WAS PERFORMED IN THE SAME MEDICAL FACILITY".

  Patient problems: Fall

  MAUDE report 15347103 ↗
• MalfunctionOct 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP THAT A CURVE METAL OBJECT WAS DETECTED THROUGH POST-OP X-RAY AND CT SCAN AFTER PATIENT WENT THROUGH A BIPOLAR HEMIARTHROPLASTY SURGERY. THE OBJECT IS LOCATING NEAR TO STRYKER UHR BIPOLAR COMPONENT AND FEMORAL METAL HEAD. PATIENT DOES NOT HAVE ANY COMPLICATION. THE OBJECT MIGHT AFFECT THE OPERATED JOINT ARTICULATION IN FUTURE. SURGICAL TEAM IS OBSERVING THE PATIENT FOR NEXT 3 MONTHS. DATE OF THE BIPOLAR HEMIARTHROPLASTY SURGERY: (B)(6) 2020. AS PER SALES CONFIRMATION, HOSPITAL IS NOT ABLE TO PROVIDE THE ADDITIONAL INFORMATION SUCH AS X-RAY PHOTO, DUE TO PDPA IN THE COUNTRY.

  Patient problems: Insufficient Information

  MAUDE report 10703940 ↗