MalfunctionIQO
COMP RVS HMRLTRL 44STD-36STD
Received Feb 4, 2016 · Event occurred Jan 11, 2016
Report 0001825034-2016-00362 · MDR key 5410274
Device
Generic name
Device, Prosthesis Alignment
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
405940
Lot number
ZB150401
Product problems
- Break
- Break
Patient
70 YR
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.
Description of Event or Problem
IT WAS REPORTED THAT DURING AN INITIAL REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2016, THE POST ON THE HUMERAL TRAY TRIAL FRACTURED OFF INTO THE TRIAL STEM. THE FRACTURED PIECE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY.