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 Extravasation (1842)

Event Date 02/21/2019

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2019, zimmer knee creations was notified of a patient reported adverse event via report number mw5091273.A patient underwent an initial subchondroplasty procedure on (b)(6) 2019, and then reported to have pain an complete loss of feeling in their knee and could not walk after surgery with an unknown onset date.The patient returned on an unknown date to a health care professional's office, where radiographic images were taken, and it was determined that the accufill implant had migrated outside of the bone.On an unknown date, the patient returned to surgery to remove the accufill.The product was not returned for the investigation.The dhr was unable to be reviewed, as the lot number for the device related to the event was unable to be confirmed.Once additional information becomes available, a supplemental report will be submitted.

Event Description

Patient reports pain and extravasation in knee after scp procedure.

Event Description

Patient reports pain and complete loss of feeling in knee.

Manufacturer Narrative

Fda medwatch report states that the patient had scp treatment procedure of the knee on (b)(6) 2019.The patient reported to the fda in november 2019 that she had knee pain, loss of feeling, and could not walk after surgery.The report further states that x-ray showed cement material outside of the bone and surgery was performed to remove the material, and that the patient returned to the doctor¿s office for surgery in order to remove the accufill.Multiple attempts were made to contact the patient using the information on the medwatch report with no success.The report of x-ray findings of cement outside of the bone show evidence that incorrect procedure or technique was performed at the time of initial surgery.Cement outside the bone or targeted area could be a result of a few factors including over-injection of too much material into the bone or incorrect inter-operative x-ray use during surgery to target the bone during surgery.No further information is available to determine the exact cause or nature of the complaint.The cause of the complaint is indeterminate.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.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 9587666
• MDR Text Key: 178109633
• Report Number: 3008812173-2020-00003
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 11/22/2019,07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• 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: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 11/22/2019
• Distributor Facility Aware Date: 12/11/2019
• Event Location: Hospital
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other