EXETER 0580-1-502Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540153371), received between Nov 2, 2017 and Mar 4, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fitting Problem” (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.
Most reported problems
Device problems
- Fitting Problem1
- Insufficient Device Problem Information1
Patient problems
- Inflammation1
- Injury1
- No Consequences Or Impact To Patient1
- Reaction1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
THE SURGEON, REPORTED THAT HE UNDERTOOK A REVISION OF AN EXETER MITCH COMBINATION WHICH HAD BEEN IMPLANTED INTO THE PATIENT'S RIGHT HIP IN 2007.
Patient problems: Inflammation; Injury; Reaction
MAUDE report 8386330 ↗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 6996279 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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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