19MM ACL SUTURE BUTTON
Received Nov 19, 2013 · Event occurred Oct 11, 2013
Report 0001825034-2013-05420 · MDR key 3477616
Device
Generic name
Retention Device, Suture
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
904219
Lot number
386490
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
IT WAS REPORTED A PATIENT UNDERWENT ACL RECONSTRUCTION ON (B)(6) 2013. SUBSEQUENTLY, THE PATIENT¿S KNEE BECAME INFECTED ON (B)(6) 2013. IT IS UNKNOWN IF THE PATIENT HAS BEEN REVISED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.
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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, ¿EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION¿ REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4). THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-05419/05420).