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

Model Number N/A

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

Patient Problem No Code Available (3191)

Event Date 02/04/2019

Event Type  Injury  

Manufacturer Narrative

Patient (b)(6) underwent a total knee arthroplasty on (b)(6) 2019 due to osteoarthritis after undergoing an initial subchondroplasty procedure on (b)(6) 2018.The physician classified this event as possibly related to the subchondroplasty procedure but not related to the accufill implant.The patient had a previous corticosteroid injections and left tha in 2015.The clinical project lead was notified on (b)(6) 2019.Once additional information becomes available, a follow-up report will be submitted.A dhr review cannot be completed as the lot number of the device in questions are unknown; the device cannot be returned for investigation since it remains 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 right total knee replacement on (b)(6) 2019.

Manufacturer Narrative

The operative notes for subject (b)(6) were received from the site on june 3rd, 2019.They will be reviewed as a part of the investigation.The investigation is ongoing.

Event Description

Clinical subject (b)(6) experienced a right total knee replacement on (b)(6) 2019.

Event Description

Clinical subject (b)(6) experienced a right total knee replacement on (b)(6) 2019.

Manufacturer Narrative

The patient had previous corticosteroid injections and left tha in 2015.The patient underwent the initial scp surgery on (b)(6) 2018 and also underwent a partial medial and partial lateral meniscectomy.Intraoperatively, it was noted that the articular surface of the patella and trochlea showed areas of grade 2 change.Additionally, there were grade 4 changes on the lateral tibial plateau and a gentle abrasion arthroplasty was performed.The lateral femoral condyle showed some grade 3 changes.A complex tearing throughout the lateral meniscus was noted.3cc of accufill was injected in the lateral femoral condyle and 2.5cc were injected in to the tibia during the scp surgery.There were no intraoperative complications noted.The clinical project lead was notified on april 22, 2019 that the patient had been revised to tka on (b)(6) 2019 by another surgeon.No additional information is available regarding the revision.Review of the scp surgical notes indicates the procedure proceeded as planned.The patient has been removed from the study.This complaint is being closed based on lack of available information regarding the revision surgery.If additional information is made available, the complaint will be reopened.The dhr was unable to be reviewed, as the lot number for the device related to the event was unable to be confirmed.The product was not returned for the investigation, as it remains implanted in the patient.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8625489
• MDR Text Key: 145602808
• Report Number: 3008812173-2019-00030
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/22/2019
• 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: 75 YR
• Patient Weight: 68