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.

Manufacturer Narrative

The x-ray imagine results and operative notes were received for the event.The review of the x-ray imaging results taken were obtained from the clinical project lead.On (b)(6) 2018 the findings were: there was a slight increase in sclerosis at the cuboid bone, raising the possibility of stress fracture.There was no substantial arthrosis.There is no focal soft tissue abnormality.On (b)(6) 2018, the findings were: an increased density at the cuboid consistent with patient's history of calcium phosphate cement internal fixation.Talotibial osteoarthritis.There is no focal soft tissue abnormality.The impression was: stable appearing postoperatiev changes of the cuboid.The operative notes for the event were also reviewed, and the procedure progressed without incident.

Event Description

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

Manufacturer Narrative

The operative notes were reviewed and it was found that 1.5 ccs of accufill were used to treat a cuboid bml, which are in alignment with the technique guide.The patient presented with baseline pain at first office visit of 4 (4 of 10), at 6 weeks had demonstrated increased pain level (7 of 10) and (5 of 10) on the 3 and 6 month office visits.No further surgical intervention has been at the time of the adverse event.Surgeon reported that pain and swelling as probably related to implant.No adverse remarks were made during index surgery.The 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 no nonconformances related to the incident were reported.

Event Description

Clinical subject (b)(4) 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
• 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
• 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,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: Health Professional
• 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
• 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
• 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: 44 YR
• Patient Weight: 75