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 Extravasation (1842)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2019, zimmer knee creations was notified that on (b)(6) 2019 that the accufill had extravasated during the index procedure.The cement was removed with arthroscopic shaver and lavage.A synovectomy, debridement, and a medial partial meniscectomy.The patient has left knee oa for which they have previously tried pt, corticosteroid injections and a knee brace.The device will not be returned for investigation, as it remains implanted in the patient.Once additional information becomes available about the event, a supplemental report will be submitted.

Event Description

Extravasation of accufill was noted during the index procedure of clinical study subject (b)(6).

Manufacturer Narrative

Scp knee randomized controlled trial subject (b)(6) underwent the initial subchondroplasty procedure on (b)(6) 2019 for a single bone marrow lesion in their left medial femoral condyle.A debridement, a synovectomy, and a medial partial meniscectomy were also performed concomitantly.The operative notes of were provided for the investigation.The surgeon confirmed the location of the cannula fluroscopically, 2.5cc of accufill was injected, the cannula was left in place for 10 minutes to let the implant harden, the cannula was removed and there was no evidence of extravasation after the cannula was removed.There was some extravasation of the cement material during implantation, which was removed with an arthroscopic shaver and lavage.The patient woke up from the anesthesia without incident and was then transferred to the recovery room in stable condition.Per the health care professional, this event was possibly related to the study surgical procedure (scp with arthroscopy) and probably related to the accufill implant.The event was most likely caused by the patient anatomy and clinical conditions.A review of the finished goods dhr was conducted, and there were no nonconformances related to the complaint condition noted.The device in question remains implanted in the patient and therefore was not returned for the investigation.

Event Description

Extravasation of accufill was noted during the index procedure of clinical study subject (b)(6).

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8995519
• MDR Text Key: 157780068
• Report Number: 3008812173-2019-00044
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 00889024205314
• UDI-Public: 00889024205314
• Combination Product (y/n): N
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2021
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC05347
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/31/2019
• Device Age: 11 MO
• Event Location: Hospital
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 119