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

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that there was delayed hardening of accufill during an index procedure.The operative notes and adverse event form were returned as a part of the investigation.The device will not be returned, as it remains implanted in the patient.Once additional information becomes available about the event, a supplemental report will be submitted.Initially, this was deemed a non reportable event until additional information was received on (b)(6) 2019 that changed the reportability of the event.
Event or Problem Description
Clinical subject (b)(6) experienced delayed scp hardening (b)(6) 2019.
Additional Manufacturer Narrative
It was reported that there was delayed hardening of accufill during an index subchondroplasty procedure performed on (b)(6) 2019.Zimmer knee creations was notified of the event on (b)(6) 2019, and the reportability was reassessed on mar 29, 2019 when new information was received.The initial report was submitted on apr 25, 2019.The operative notes and adverse event form were returned and reviewed as a part of the investigation.It has been noted that extended arthroscopy can result in joint cooling.The impact of the joint cooled below normal body temperature could lead to delayed setting of the accufill.This was communicated to surgical site.The patient is retained in the study and will continue to be monitored.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 or Problem Description
Clinical subject (b)(6) experienced delayed scp hardening (b)(6) 2019.

• Brand Name: SUBCHONDROPLASTY
• Common Device Name: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8552238
• Report Number: 3008812173-2019-00025
• Device Sequence Number: 16233476
• Product Code: OJH
• UDI-Device Identifier: 00889024205321
• UDI-Public: 00889024205321
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2022
• Device Model Number: N/A
• Device Catalogue Number: 414.503
• Device Lot Number: KC05710
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 08/21/2019
• 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
• Patient Age: 31 YR
• Patient Weight: 128