SHOULDER SYSTEM
Received Jul 8, 2026 · Event occurred Jun 12, 2026
Report 3005180920-2026-00665 · MDR key 25747741
Device
Generic name
Short Humeral Diaphysis - Cementless - 7
Manufacturer
Medacta International SaModel number
04.01.0180Lot number
2532746
Product problems
- No Apparent Adverse Event
Patient
68 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BATCH REVIEW PERFORMED ON 25 JUN 2026 LOT 2532746: (B)(4) MANUFACTURED AND RELEASED ON 18-FEB-2026. EXPIRATION DATE: 2031-FEB-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem
DURING IMPLANT ASSEMBLY REMOVAL, THE ASSEMBLED IMPLANTS (DIAPHYSIS, METAPHYSIS, DOUBLE ECCENTRIC, METAL HEAD) DETACHED FROM THE BACK TABLE AND FELL TO THE FLOOR. THE MID-STEM COMPONENT BECAME TRAPPED IN THE PLASTIC BASE. DIFFERENT IMPLANT SIZES WERE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A DELAY OF 30 MINUTES OCCURRED TO RETRIEVE AND REPLACE THE REQUIRED DEVICES.