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 No Code Available (3191)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2017, a patient underwent an initial subchondroplasty procedure.On september 23, 2019, zimmer knee creations became aware of the adverse event of osteoarthritis which resulted in a partial knee replacement of the medial tibial plateau that occurred on (b)(6) 2019.The health care professional assessed the event and determined it was possible related to the subchondroplasty study procedure and not related the accufill implant.The operative notes for the event were requested from the clinical project lead.The product was not returned for the investigation, as it remains implanted in the patient.The dhr was unable to be reviewed, as the lot number for the device related to the event was unable to be confirmed.Device remains implanted in the patient.

Event Description

Subject (b)(6) adverse event of partial knee replacement after scp.

Event Description

Subject 20-0138 adverse event of partial knee replacement after scp.

Manufacturer Narrative

Subject 20-0138 of the subchondroplasty observational knee study received an accufill implant during the index procedure on (b)(6) 2017.The pre-operative diagnosis was complex tears of the medial and lateral meniscus, chondromalacia, and insufficiency fracture of the tibia, all of the right knee.Prior to the index procedure, the patient had undergone corticosteroid injections, viscosupplementation, unloader bracing and physical therapy to attempt to address the pain.The preoperative diagnosis was confirmed during the index procedure.In addition to the delivery of 3.2cc¿s of accufill to the location of the tibial insufficiency fracture, a partial lateral meniscectomy and amniotic allograft tissue injection was performed.Following the procedure, the patient awoke successfully from general anesthesia in stable condition.Following the index procedure, the patient experienced an adverse event of osteoarthritis, but the date of onset was not reported.The condition resulted in a partial knee replacement of the medial tibial plateau on (b)(6) 2019.The health care professional reported this event was possibly related to the subchondroplasty study procedure but not related the accufill implant.Although a definitive root cause cannot be determined, the event is most likely associated with the patient¿s osteoarthritic condition.The dhr was unable to be reviewed, as the lot number for the device related to the event was unable to be confirmed.The device in question remains implanted in the patient and therefore was not returned for the investigation.There were no images available for review.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 9217786
• MDR Text Key: 163128402
• Report Number: 3008812173-2019-00049
• 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: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• 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
• Distributor Facility Aware Date: 09/23/2019
• Event Location: Hospital
• Date Manufacturer Received: 09/23/2019
• 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: 79 YR
• Patient Weight: 79