AEQUALIS REVERSED MULTIDIR SCREW D4.5 L 26 STERILE
Received Jul 27, 2026 · Event occurred Jul 3, 2026
Report 3000931034-2026-00586 · MDR key 50046197
Device
Generic name
Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Manufacturer
Tornier S.a.s.Catalog number
DWD126
Lot number
Unknown
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- 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 was not possible because the lot number was not communicated. No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities. Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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.Infections are often caused by a multitude of factors such as comorbidity of the patient, the trauma, the surgical intervention, and the aftercare.If the device is returned or if any additional information is provided, the investigation will be reassessed.