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 Problems Edema (1820); Pain (1994)

Event Date 12/28/2018

Event Type  Injury  

Manufacturer Narrative

Subject (b)(6) experienced a left ankle edema and pain 6 weeks post scp® procedure.The baseline numeric pain score was 6 out of 10.At 2 weeks after surgery, the pain score was 2; at 6 weeks the score was 8.The patient was prescribed medications for increased left ankle pain and swelling.The event was evaluated as moderate in intensity, definitely related to the procedure and possibly related to the implant and is ongoing.The device cannot be returned for investigation since it was implanted.As additional information about the event is reported, a supplemental report will be submitted with any additional findings.

Event Description

Clinical subject (b)(6) experienced a left ankle edema and pain 6 weeks post scp® procedure.

Manufacturer Narrative

Patient (b)(6) was entered into the study (b)(6) 2018.One cc of accufill was used to treat a cuboid bml.No adverse remarks were made during index surgery.The patient presented with initial pain reduction at 2 weeks (2 of 10) but at 6 weeks had demonstrated increased pain level (8 of 10).On (b)(6) 2018, patient received a cortisone injection to address increased pain and swelling.Surgeon reported that pain and swelling as possibly related to implant.This patient will continue to be monitored through the clinical study, and the complaint will be reopened if additional information is obtained.A review of the dhr was conducted, and there were no nonconformances related to the complaint condition noted.

Event Description

Clinical subject (b)(6) experienced a left ankle edema and pain 6 weeks post scp® procedure.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8331373
• MDR Text Key: 135879837
• Report Number: 3008812173-2019-00005
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2021
• Device Model Number: N/A
• Device Catalogue Number: 514.315
• Device Lot Number: KC04977
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 11 MO
• Date Manufacturer Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 75