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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/19/2018

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2018, a clinical study patient underwent the scp procedure on their right cuboid; there were no complications reported intra-operatively. After the six month follow up, the subject reported an increase in pain from the baseline of "4" to a "5. " an mri was performed on (b)(6) 2018, which showed a decreased edema. The subject was prescribed a tens unit on (b)(6) 2018 for pain. Event is on-going. The device was not returned for investigation, as it remains implanted in the patient. If additional information is available, a supplemental will be submitted.

Event Description

Clinical subject (b)(6) pain score increased after scp surgery.

• 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: 8196002
• MDR Text Key: 131393405
• Report Number: 3008812173-2018-00041
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 402.203
• Device Lot Number: KC05031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/07/2018
• Device Age: 8 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2018
• 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 Treatment Data

Date Received: 12/26/2018 Patient Sequence Number: 1