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	No Code Available (3191)
Date of Event	01/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event was received on january 22nd, 2019.As reported, the cause for the event was unknown; the surgical was limited to 15 minutes.The patient recovered within the delay time frame and there had been no known impact to the patient at that time.After completion of the investigation, it was communicated on june 27th, 2019 that the event may have been related to a fat embolism associated with the pressure gradient and associated with the risk of surgery.During the surgery, it was noted that patient's bone was weak and required little insertion force for the cannula.The surgery was completed successfully, and the patient was seen at a follow-up appointment at 12 weeks and was doing well.The device was not returned for investigation, as it remains implanted.A review of the dhr from the lot in question was conducted, and there were no anomalies related to the complaint condition.
Event or Problem Description
Notification date: 22 jan 2019.Patient's stats began to drop upon injection.

• Brand Name: SUBCHONDROPLASTY
• Common Device Name: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8817626
• Report Number: 3008812173-2019-00035
• Device Sequence Number: 342567
• Product Code: OJH
• UDI-Device Identifier: 00889024205314
• UDI-Public: 00889024205314
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Report Date (Section B): 07/22/2019

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: 09/07/2021
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC05347
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 5 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 07/23/2019
• 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