INSTRUMENT 0939-0-002MRecalls & reported problems
Howmedica Osteonics Corp. · EXETER PLUG INTRODUCER · Class 2
All models of INSTRUMENT (131)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327196047), received between Apr 21, 2026 and Apr 21, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Material Fragmentation1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2026Fracture; Material Fragmentation
THE FOLLOWING INFORMATION WAS PROVIDED: "DURING THE GMRS DISTAL FEMUR PROCEDURE, AN EXETER INTRAMEDULLARY PLUG WAS BEING INSERTED INTO FEMUR. THE REQUIRED DEPTH HAD NOT YET BEEN REACHED WHEN THE INSERTER SUDDENLY GAVE WAY. PLUG INTRODUCER WAS WITHDRAWN, AND IT WAS NOTED THAT THE TIP HAD BROKEN OFF. THE DEPTH WAS INSUFFICIENT. THE TIP PLUG INTRODUCER HAD PENETRATED THROUGH THE FEMUR, A FLUOROSCOPIC IMAGE WAS TAKEN. DUE TO THIS PERFORATION, THE SURGEON DECIDED THAT AN EXTENSION PIECE WAS REQUIRED TO ALLOW THE STEM TO BYPASS THE DAMAGED AREA. THE 17 MM STEM THAT HAD BEEN PREPARED WAS TOO LARGE AFTER RE-CUTTING, AND A SMALLER ONE HAD TO BE SELECTED. A STRYKER REPRESENTATIVE WAS PRESENT IN THE OPERATING ROOM PROVIDING TECHNICAL SUPPORT." THE FEMUR HAD TO BE CUT 60 MM MORE THAN ORIGINALLY WAS PLANNED BECAUSE THE SURGEON WANTED THE STEM TO EXTEND OVER THE PENETRATION POINT.
Patient problems: Bone Fracture(s)
MAUDE report 24936439 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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