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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	02/26/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Potential for extravasation into ankle joint post scp.
Event or Problem Description
Potential for extravasation into ankle joint post scp.
Additional 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
• Common Device Name: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8579378
• Report Number: 3008812173-2019-00026
• Device Sequence Number: 16596601
• Product Code: OJH
• UDI-Device Identifier: 00889024205345
• UDI-Public: 00889024205345
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other