TORNIER SIMPLICITI HUM HEADSIZE 4 6X17
Received Sep 19, 2024 · Event occurred Apr 27, 2017
Report 0001649390-2024-00544 · MDR key 20254591
Device
Generic name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem
Manufacturer
Tornier IncCatalog number
7122871
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
69 YR · Male
- Rupture
- Rupture
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
AS REPORTED: "SUBJECT (B)(6) SHOUT - TORNIER SHOULDER OUTCOMES STUDY. ROTATOR CUFF TEAR (SIGNIFICANT / NOT PRESENT PRE-OP), SPRAIN OF LEFT ROTATOR CUFF CAPSULE. SUBACROMIAL DECOMPRESSION, CAPSULAR RELEASE, ROTATOR CUFF REPAIR, AND ARTHROSCOPY ON (B)(6) 2017"