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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Host-Tissue Reaction (1297)

Event Date 05/26/2016

Event Type  Injury  

Manufacturer Narrative

This event was previously submitted on 0001825034-2018-01702.Patient stated that the ankle underwent core depression followed by ankle necrosis.Additional information about the event is pending the operative note and the investigation.Once additional information is obtained, a follow up report will be submitted.

Event Description

Bone filler spreading.

Manufacturer Narrative

The operative notes and x-rays submitted from the patient, and it was determined there was insufficient information available to determine the exact root cause of the complaint condition.Possible contributes to the complaint condition could be over filling of the material into the defect area.

Event Description

Bone filler spreading.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer (Section G): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer Contact: shari bailey ; 841 springdale drive; exton, PA 19341 ; 4848794543
• MDR Report Key: 7561751
• MDR Text Key: 109818134
• Report Number: 3008812173-2018-00022
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2019
• Device Model Number: N/A
• Device Catalogue Number: 514.503
• Device Lot Number: KC02804
• Other Device ID Number: N/A
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR