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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pulmonary Embolism (1498); Thrombosis (2100)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

Communication was received from a sales representative that a patient developed an dvt/pe after subchondroplasty.The product information and details of the event are unknown at this time.A supplemental report will be submitted once additional information is obtained regarding the event.

Event Description

Patient developed dvt/pe after subchondroplasty.

Event Description

Patient developed dvt/pe after subchondroplasty 1/2.

Manufacturer Narrative

After speaking with the sales representative about the event, it was communicated from the surgeon to the sales representative that he was unaware of the event and which patient the event was about.The was no additional information provided about the event.The product was not returned for the investigation, as it remains implanted in the patient.The dhr was unable to be reviewed, as the lot number for the device related to the event was unable to be confirmed.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8438075
• MDR Text Key: 139376567
• Report Number: 3008812173-2019-00012
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other