MalfunctionJDG
R3 OFFSET IMPACTOR
Received Jun 16, 2026 · Event occurred May 22, 2026
Report 1020279-2026-00834 · MDR key 25523787
Device
Generic name
Prosthesis, Hip, Femoral Component, Cemented, Metal
Manufacturer
Smith & Nephew, Inc.Catalog number
71368569
Lot number
23AM15021
Product problems
- Fracture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INTERNAL COMPLAINT REFERENCE: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT, DURING THA, ONE (1) R3 OFFSET IMPACTOR WAS CHIPPED DURING STANDARD USAGE. NO PIECES FELL INSIDE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.