TORNIER FLEX SHOULDER SYS REVINSERT 39MM 6TH C 7.5DG
Received Jul 28, 2026 · Event occurred Jul 3, 2026
Report 3000931034-2026-00590 · MDR key 50054851
Device
Generic name
Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Manufacturer
Tornier S.a.s.Catalog number
DWF391C
Lot number
9271BA
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Male
- Post Operative Wound Infection
Narrative
Description of Event or Problem
A revision surgery was performed due to infection.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the Device History for the reported lot did not indicate any abnormalities. No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities. No indications of material, manufacturing or design related problems were found during the investigation.Surgical site infections (SSIs) are a well-documented and relatively common complication following surgical procedures, with a global incidence of approximately 11% in general surgeries (Gillespie, et al., 2021). In trauma surgeries, the risk is often elevated due to factors such as emergency conditions, open fractures, and limited time for optimal preoperative preparation. While it is theoretically possible for an infection to stem from a breach in the sterilization process at the manufacturing site, such occurrences are highly unlikely given the rigorous quality control systems, validated sterilization methods, and multiple checkpoints in place. More commonly, infections may arise from breaches in sterile techniques during handling, storage, or surgery itself¿such as compromised packaging, improper transfer of the implant, or contamination during the procedure. Another main cause of post-operative wound infections (superficial and deep) may be related to post-operative factors, such as the open wound (even when closed with stitches/ staples), wound care/ hygiene, swelling/edema (inflammation), post-operative hematoma, etc. Additionally, patient-related factors, including their own microbiome, represent a significant and often unavoidable source of infection.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.