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 Code Available (3191)

Event Date 04/03/2019

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2018, a patient underwent scp in an antegrade approach on the left cuboid and navicular.The cuboid was injected with 0.8 cc accufill reconstituted with saline.The navicular was injected with 0.5 cc accufill reconstituted with saline.No concomitant procedures were performed.Baseline numeric pain score fluctuated over the course of the six months post-operatively.The patient underwent an open posterior tibial debridement/repair and a kidner procedure on the index foot in (b)(6) of 2019 because of medial foot pain.Zimmer knee creations was notified of the event on (b)(6) 2019.The event was evaluated as moderate in intensity, probably procedure related and possibly related to the implant.The event is ongoing.The product was not returned for the investigation, as it remains implanted in the patient.If additional information becomes available, a supplemental report will be submitted.

Event Description

Subject 12-009 underwent revision due to pain after scp.

Manufacturer Narrative

On (b)(6)2018, subject 12-009 underwent a subchondroplasty, where 0.8cc of accufill was injected into the cuboid and 0.5cc of accufill was injected into the navicular of the left foot, which are in accordance with the surgical technique.No concomitant procedures were performed, and there were no intraoperative complications reported.The operative notes for event were requested and reviewed as a part of the investigation.Baseline numeric pain score was reported as a 9 out of 10, at two weeks post-operatively the numeric pain score was a 7 out of 10.At six weeks, the numeric pain score was a 6 out of 10 at 6; at 3 months, the numeric pain score was an 8 out of 10.Lastly, at 6 months post-operatively, the numeric pain score was reported as an 8 out of 10.On (b)(6) 2019, the patient underwent an open posterior tibial debridement/repair and a kidner procedure on the index foot (per queries in the edc this date may be incorrect) because of medial foot pain.The event was evaluated as moderate in intensity, probably procedure related and possibly related to the implant.With the information available it is not possible to determine if the event is directly related to the scp procedure or not.The injected volumes reported are appropriate for the cuboid and navicular per technique guidelines; there are no other factors reported that would indicate failure of the implant material.The exact cause of the event is indeterminate.The product was not returned for the investigation, 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

Adverse event for scp foot & ankle study for subject 12-009.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 9498382
• MDR Text Key: 172274772
• Report Number: 3008812173-2019-00056
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 00889024205352
• UDI-Public: 00889024205352
• 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: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2021
• Device Model Number: N/A
• Device Catalogue Number: 514.315
• Device Lot Number: KC05255
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/03/2019
• Device Age: 17 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PN 308.151LN: 39976
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 66