ACCUPORT
Received Jul 30, 2019 · Event occurred Aug 30, 2017
Report 3008812173-2019-00037 · MDR key 8842112
Device
Generic name
Cannula
Manufacturer
Zimmer Knee Creations, Inc.Model number
N/ACatalog number
308.151
Lot number
36904
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
30 YR
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
PATIENT UNDERWENT AN INITIAL SUBCHONDROPLASTY PROCEDURE ON (B)(6) 2017, AND NO OTHER CONCOMITANT PROCEDURES WERE PERFORMED. A REVIEW OF THE OPERATIVE NOTES FROM THE INDEX PROCEDURE INDICATES THE PROCEDURE PROCEEDED AS ANTICIPATED. THE PATIENT RETURNED TO THE DUE TO POST-OPERATIVE PAIN, AND WAS PRESCRIBED PHYSICAL THERAPY. PATIENT PAIN LEVELS RETURNED TO NORMAL AFTER 24 MONTHS. THE HEALTH CARE PROFESSIONAL ASSESSED THE ADVERSE EVENT AND DETERMINED THAT IT WAS POSSIBLY RELATED TO THE PROCEDURE AND IMPLANT. THIS PATIENT WILL CONTINUE TO BE MONITORED BY THE TREATING SURGEON. THE DEVICE IN QUESTION WAS NOT RETURNED, AS IT REMAINS IMPLANTED. A REVIEW OF THE DHR WAS CONDUCTED ON THE LOT IN QUESTION, AND NO ANOMALIES RELATED TO THE COMPLAINT CONDITION WERE NOTED.
Description of Event or Problem
CLINICAL SUBJECT (B)(6) EXPERIENCED INCREASED PAIN POST SCP