InjuryPKC

UNKNOWN SIMPLICITI IMPLANTS

Received Jul 21, 2026 · Event occurred May 20, 2026

Report 0001649390-2026-00730 · MDR key 25897804

Device

Generic name

Pros. Tot. Anatomic Shoulder, Uncem. Metaphyseal Hum. Stem No Diasphyseal Incur

Manufacturer

Tornier Inc

Catalog number

UNK_WTB

Lot number

UNKNOWN

Product problems

Malposition of Device

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

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

Description of Event or Problem

AS REPORTED: "A REVISION SURGERY SCHEDULED ON (B)(6) 2026 WHICH WAS PLANNED USING THE BLUEPRINT PLANNING FEATURE (CASE ID: (B)(4)) DUE TO MALPOSITION."