MalfunctionJDG
FEMORAL IMPLANT IMPACTOR
Received May 27, 2026 · Event occurred May 4, 2026
Report 1020279-2026-00707 · MDR key 25311017
Device
Generic name
Prosthesis, Hip, Femoral Component, Cemented, Metal
Manufacturer
Smith & Nephew, Inc.Catalog number
71440005
Lot number
18MM16214
Product problems
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H11: INTERNAL COMPLAINT REFERENCE (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT, DURING A TKA, THE GREEN PLASTIC OF ONE (1) FEMORAL IMPLANT IMPACTOR BROKE OFF. NOTHING FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.