AFFINITI PEGGED GLENOID SZ 40
Received Dec 31, 2024 · Event occurred Aug 27, 2019
Report 0001649390-2024-00736 · MDR key 21045810
Device
Generic name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem
Manufacturer
Tornier IncCatalog number
0020060
Lot number
UNKNOWN
Product problems
- Osseointegration Problem
- Osseointegration Problem
Patient
NA · Unknown
- Inadequate Osseointegration
- Implant Pain
- Inadequate Osseointegration
- Implant Pain
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 COMPONENT LOOSENING PAINFUL LEFT SHOULDER, GLENOID WEAR OR LOOSENING".