TORNIER SIMPLICITI HUM HEADSIZE 5 8X18
Received Sep 18, 2024 · Event occurred Jun 19, 2020
Report 0001649390-2024-00538 · MDR key 20244133
Device
Generic name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem
Manufacturer
Tornier IncCatalog number
7122872
Lot number
UNKNOWN
Product problems
- Device Dislodged or Dislocated
- Device Dislodged or Dislocated
Patient
47 YR · Female
- Bacterial Infection
- Inadequate Osseointegration
- Implant Pain
- Bacterial Infection
- 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
SUBJECT (B)(6) SHOUT - TORNIER SHOULDER OUTCOMES STUDY. INFECTION PAIN AND GLENOID LOOSENING. ROTATOR CUFF INSUFFICIENCY AND INFECTION. RE-OPERATION ON (B)(6) 2021; IMPLANTS REMOVED AND PLACEMENT OF ANTIBIOTIC SPACER, RE-OPERATION ON (B)(6) 2021; REMOVAL OF SPACER, RE-IMPLANTATION OF REVERSE TOTAL SHOULDER.