TORNIER FLEX SHOULDER SYS REVINSERT 39MM 6TH B 12.5DG
Received Jul 15, 2026 · Event occurred Jun 23, 2026
Report 3000931034-2026-00576 · MDR key 25830209
Device
Generic name
Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Manufacturer
Tornier S.a.s.Catalog number
DWF391B
Lot number
8385BB
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
75 YR · Male
- Bacterial Infection
- Erythema
- Inflammation
- Pain
Narrative
Description of Event or Problem
PATIENT UNDERWENT A RIGHT REVERSE SHOULDER REPLACEMENT SURGERY. WEEKS LATER, THE WOUND OVER THE SURGICAL SITE WAS OOZING FLUID, BECAME RED AND INFLAMED, AND WAS PAINFUL. CULTURE OF THE SURGICAL SITE IDENTIFIED C. ACNES BACTERIAL INFECTION. DURING THE REVISION PROCEDURE, THE SURGEON COLLECTED ADDITIONAL SPECIMENS FOR PATHOLOGY, PERFORMED DEBRIDEMENT, LAVAGED THE SURGICAL SITE, AND FINALLY REPLACED THE IMPLANTS.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.