EXETER 0580-1-373Recalls & reported problems
Howmedica Osteonics Corp. · V40 STEM · Class 2 · Implant
All models of EXETER (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540153272), received between May 31, 2017 and Nov 7, 2024 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Packaging Compromised” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Packaging Compromised1
- Fracture1
- Incomplete or Missing Packaging1
- Migration1
- Packaging Problem1
Patient problems
- Injury2
- No Consequences Or Impact To Patient2
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PRIMARY SURGERY, ARTIFICIAL HEAD REPLACEMENT SURGERY, WAS PERFORMED 12 YEARS BEFORE. REVISION SURGERY WAS PERFORMED DUE TO A PROBLEM ON THE ACETABULAR SIDE. IT WAS FOUND THAT REMOVED STEM WITH BLACK STAIN ON MEDIAL PORTION OF STEM.
Patient problems: Insufficient Information
MAUDE report 20628528 ↗InjuryJan 30, 2020Fracture; Fracture
BROKEN TRUNNION ON EXETER 37.5MM NO 3 STEM. PATIENT WAS REVISED.
Patient problems: Injury
MAUDE report 9647620 ↗InjuryJun 12, 2019Migration; Migration
THE PATIENT UNDERWENT A REVISION OF A HEMIARTHROPLASTY, ON THE RIGHT HIP, FOLLOWING PROGRESSION OF HIS DISEASE. HE PRESENTED WITH GROIN PAIN BELIEVED TO BE DUE TO ACETABULAR WEAR. THERE WAS ALSO SOME SUBSIDENCE OF THE FEMORAL STEM. THE STEM AND BI POLAR HEAD WERE REMOVED, AND THE ACETABULUM WAS REVISED AND A SHORT STEM CEMENTED INTO THE REMAINING CEMENT MANTLE.
Patient problems: Injury; Pain
MAUDE report 8691180 ↗MalfunctionJun 27, 2018Device Packaging Compromised; Device Packaging Compromised
NURSE (B)(6) INFORMED SALES REP THAT ITEM REF 0580-1-373, LOT G5861841 COULD NOT BE OPENED IN STERILE WAY DURING THE OPERATION. NEW IMPLANT HAD BEEN TAKEN TO CONTINUE OPERATION. OPERATION WAS COMPLETED SUCCESSFULLY, NO DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7640925 ↗MalfunctionMay 31, 2017Incomplete or Missing Packaging; Packaging Problem; Packaging Problem
WHEN THE STEM PACKAGE WAS OPENED DURING SURGERY, IT WAS NOTICED THAT THE SPIGOT AT THE NECK WAS NOT IN THE PACKAGE. THERE WAS NO SURGICAL DELAY BECAUSE THE STAFF JUST OPENED ANOTHER STEM PACKAGE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6600596 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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