inforMED
InjuryPKC

UNKNOWN SIMPLICITI IMPLANTS

Received Jun 9, 2026 · Event occurred Mar 24, 2026

Report 0001649390-2026-00539 · MDR key 25445347

Device

Generic name

Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem

Manufacturer

Tornier Inc

Catalog number

UNK_WTB

Lot number

UNKNOWN

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Muscle/Tendon Damage

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO SUBSCAP FAILURE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.