MalfunctionKRR
HTR POLYMER IMPLANT
Received Jun 21, 2016 · Event occurred Jun 13, 2016
Report MW5063013 · MDR key 5748395
Device
Product problems
- Nonstandard Device
Patient
54 YR
- No Information
- No Information
Narrative
Description of Event or Problem
NOTIFIED TODAY (B)(6) 2016 OF AN URGENT PRODUCT RECALL BY BIOMET MICROFIXATION INVOLVING THE HARD TISSUE REPLACEMENT POLYMER IMPLANTS. IN REVIEWING OUR RECORDS, WE HAD 2 OF THE RECALLED ITEMS AT OUR FACILITY. ONE NOT IMPLANTED AND RETURNED TO COMPANY. THE OTHER IMPLANTED IN PT NAMED IN THIS FORM.