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

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problems Host-Tissue Reaction (1297); Unspecified Infection (1930)

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

Zimmer knee creations became aware of the reported event on (b)(4) 2018; this complaint was reported to the fda through mw5074629.The patient had been experiencing a tissue reaction about 2.5 weeks post subchondroplasty procedure and had been in and out of the hospital since surgery to address the issue.The patient had been treated with antibiotics via picc line.The date of the event was (b)(6) 2017.Attempts to follow up and investigate are in motion.

Event Description

Medwatch form received.Notification date : (b)(4) 2018.Reported femoral condyle began to drain.

Manufacturer Narrative

Additional information was unable to be obtained, as there was no contact information provided along with the mw5074629 report.A review on the complaints in the system showed no known possible linkages to the reported event.In the event new information is obtained for this event, the complaint record will be further investigated.

Event Description

Notification date : (b)(6) 2018 reported femoral condyle began to drain.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 7322201
• MDR Text Key: 101834244
• Report Number: 3008812173-2018-00008
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/16/2018,03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• 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
• Other Device ID Number: N/A
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/16/2018
• Event Location: Hospital
• Date Manufacturer Received: 02/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other