EXETER 0580-3-371Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327123739), received between Oct 2, 2023 and Jun 30, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: A HEALTHCARE PROFESSIONAL REPORTED A PATIENT WHO UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY AT ANOTHER HOSPITAL USING THE COMPANY¿S IMPLANTS. POSTOPERATIVELY, THE PATIENT HAS BEEN EXPERIENCING VARIOUS NONSPECIFIC SYMPTOMS. THE PATIENT AND FAMILY RAISED A CONCERN REGARDING A POTENTIAL METAL ALLERGY BASED ON INFORMATION OBTAINED FROM THE INTERNET. THE REPORTING HEALTHCARE PROFESSIONAL CONSIDERS THE LIKELIHOOD OF METAL ALLERGY TO BE VERY LOW FROM A CLINICAL PERSPECTIVE. NO DEFINITIVE DIAGNOSIS OF METAL ALLERGY HAS BEEN MADE, AND NO CAUSAL RELATIONSHIP BETWEEN THE REPORTED SYMPTOMS AND THE IMPLANTS HAS BEEN ESTABLISHED.

  Patient problems: High metal ion levels; Metal Related Pathology

  MAUDE report 25670741 ↗
• InjuryApr 14, 2026Loss of Osseointegration

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISION EXETER STEM AND HEAD DUE TO LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24870084 ↗
• InjurySep 29, 2025Mechanical Problem; Mechanical Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED BECAUSE THE PATIENT FELT HER RIGHT LEG WAS SHORTER THAN THE LEFT. A STEM, HEAD AND LINER WERE REVISED. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Unequal Limb Length

  MAUDE report 23166033 ↗
• InjuryOct 2, 2023Loss of Osseointegration; Loss of Osseointegration

  THA WAS PERFORMED USING OTHER COMPANY'S DEVICES (PRIMARY SURGERY DATE IS UNDER CONFIRMATION). BECAUSE OF LOOSENING, REVISION SURGERY WAS PERFORMED AND STRYKER'S THA DEVICES INCLUDING EXETER V40 STEM WERE IMPLANTED (REVISION SURGERY DATE IS UNDER CONFIRMATION). ON (B)(6) 2023, RE-REVISION WAS PERFORMED DUE TO LOOSENING. WHILE THE IMPLANT REPLACEMENT ON THE ACETABULAR SIDE WAS COMPLETED, THE FEMORAL IMPLANT REPLACEMENT WAS POSTPONED BECAUSE OF REAMER BROKEN. THE SURGEON TOLD THAT ABOUT A MONTH LATER, WHEN THE PATIENT IS READY FOR SURGERY, HE WILL PERFORM THE SURGERY AGAIN AND TREAT THE FEMORAL SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17850644 ↗