PRELUDE PF IMPACTOR
Received Dec 16, 2015 · Event occurred Nov 23, 2015
Report 0001825034-2015-05061 · MDR key 5304178
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
110004172
Lot number
979740
Product problems
- Fracture
Patient
Not reported
- No Known Impact Or Consequence To Patient
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. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER CARE AND HANDLING OF INSTRUMENTS, IT STATES, ¿SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FOR A VARIETY OF REASONS INCLUDING PROLONGED USE, MISUSE, ROUGH OR IMPROPER HANDLING.¿
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL PATELLOFEMORAL ARTHROPLASTY ON (B)(6) 2015. DURING THE PROCEDURE, THE IMPACTOR FRACTURED. NO PIECES OF THE FRACTURED INSTRUMENT FELL INTO THE PATIENT, AND THE FRACTURE DID NOT RESULT IN A PROCEDURAL DELAY.