MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. SUBCHONDROPLASTY; SCP KIT

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that approximately 1cc of accufill extravasated into the joint due to cortical perforation when the cannula was introduced.The accufill was evacuated and irrigated.The patient was awoken from anesthesia and taken back to recovery in stable condition.If additional information becomes available, an additional report will be submitted.

Event Description

Accufill extravasated into the joint.

Manufacturer Narrative

It was reported that approximately 1cc of accufill extravasated into the joint due to cortical perforation when the cannula was introduced.During the procedure on (b)(6) 2018, the surgeon perforated the contralateral cortical wall which, during the accufill injection step of the scp procedure, was the source of extravasation.The extravasated accufill was identified and removed per standard surgical technique.The procedure proceeded as anticipated and the patient remains in the clinical cohort.

Event Description

Accufill extravasated into the joint.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 7933712
• MDR Text Key: 122643629
• Report Number: 3008812173-2018-00036
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2020
• Device Model Number: N/A
• Device Catalogue Number: 514.503
• Device Lot Number: KC04571
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/04/2018
• Device Age: 11 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 10/04/2018
• Supplement Dates Manufacturer Received: 09/04/2018
• Supplement Dates FDA Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 105