TORNIER SIMPLICITI NUCLEUS SIZE 1
Received Sep 19, 2024 · Event occurred Apr 27, 2017
Report 0001649390-2024-00543 · MDR key 20254588
Device
Generic name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem
Manufacturer
Tornier IncCatalog number
DWG401
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
PLEASE NOTE CORRECTION TO D4 (CATALOG#). THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE 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. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.
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."
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".
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.