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

Model Number N/A

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

Patient Problem Necrosis (1971)

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that a year after an initial subchondroplasty procedure, the patient was diagnosed with avascular necrosis of the talus.The investigation is ongoing.Once additional information becomes available, a supplemental report will be submitted.

Event Description

Avn after scp.

Manufacturer Narrative

The initial subchondroplasty procedure was performed on (b)(6) 2018.A year later, the patient was presented with avascular necrosis of the talus with the notification date of (b)(6) 2019.A postoperative mri was provided for review.The procedure was reviewed with the site's clinical advisory board, who stated that the target site was a subtalar osteochondral lesion with cystic change and surrounding bml and that the patient was a good candidate for scp.The lesion location corresponds closely to the blood supply from the posterior tibial artery - the only supply to the talar body (the talus, like the navicular, has a famously tenuous blood supply and is prone to avn).The injection was determined to be in the correct spot, and the injected volume appeared to be about 3-5cc was injected.The clinical opinion was that too much accufill was injected into the talus during this procedure, leading to the clinical changes.The volume recommendation in scp surgical technique guide and surgical courses for scp treatment of the talar body is 1 to 1 ½ cc of accufill.This complaint is being closed based on surgical technique.The responsible surgeon has been made aware of these findings.The product was not returned for evaluation, as it remains implanted in the patient.The dhr for the raw material and finished goods lot was reviewed, and no anomalies related to the complaint condition were noted.

Event Description

Avn after scp.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8489017
• MDR Text Key: 141108939
• Report Number: 3008812173-2019-00018
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 514.503
• Device Lot Number: KC03668
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/21/2019
• Device Age: 28 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR