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 02/26/2018

Event Type  Injury  

Manufacturer Narrative

On the scp surgeon notes at time of the (b)(6) 2018 surgery on (b)(6) 2018, potential for extravasation of product into ankle joint post procedure.At the time of the event, the surgeon alleged a problem with the accufill contained inside the scp kit by filling out a hospital form, but never submitted it to the appropriate personnel at the hospital, and never informed the sales rep that there was an issue.In following up with hospital personnel recently to find out if there had been any findings, he discovered he had never submitted the form, and the hospital is now providing us with the information.The device cannot be returned for investigation since it was implanted.As additional information about the event is reported, a supplemental report will be submitted with any additional findings.

Event Description

Potential for extravasation into ankle joint post scp.

Event Description

Potential for extravasation into ankle joint post scp.

Manufacturer Narrative

The reported event of extravasation of accufill occurred on (b)(6) 2018.The event was communicated to zimmer on (b)(6) 2019.Per the reported information the surgeon alleged a problem at the time of the procedure on (b)(6) 2018 by filling out a hospital form, but never submitted it to the appropriate personnel at the hospital, and never informed the sales rep that there was an issue.In following up with hospital personnel recently to find out if there had been any findings, he discovered he had never submitted the form, and the hospital is now providing us with the information.The attending sales representative was contacted regarding details of the case.Due to the timeline of the events, the sales representative was unsure of specific details of the case.The distributor was also contacted about the case who believed the accufill was flushed out after the extravasation.Details regarding the technique were not provided.Radiographic images were requested but not provided.The dhr for the raw material and finished goods lot was reviewed, and no anomalies related to the complaint condition were noted.The product was not returned for the investigation, as it remains implanted in the patient.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8579378
• MDR Text Key: 144014423
• Report Number: 3008812173-2019-00026
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 00889024205345
• UDI-Public: 00889024205345
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2020
• Device Model Number: N/A
• Device Catalogue Number: 514.303
• Device Lot Number: KC04137
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 10 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 05/03/2019
• Supplement Dates Manufacturer Received: 04/11/2019
• Supplement Dates FDA Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other