MAUDE Adverse Event Report: NOVOSOURCE, LLC NOVOKNEE; TOTAL KNEE

Model Number	3101-1202
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Medwatch form 3500 completed by patient.Description of event or problem in the reporters own words transcribed from report number mw#5111413: i had a total knee replacement on "(b)(6) 2021" have had swelling and severe pain.On (b)(6) 2022 i went to my surgeon and he did x-rays, and blood work said everything was fine.Then i went back to him again (b)(6) 2022 and he drained fluid off my knee and ordered a bone scan for (b)(6) 2022 i waited until my next appointment with him on (b)(6) 2022 he then told me that my knee was loose and i would have to have revision surgery.My husband asked him what about if this doesn't work he then said he would just have to amputate above the knee.Fda safety report id# (b)(4).
Additional Manufacturer Narrative
This response is predicated entirely on the patient's alleged injuries.Novosource, llc is filing this response purely out of an abundance of regulatory caution.We have followed our equality management system which has led us to conclude that a responsive filing is unnecessary.However, since this has been reported to medwatch we believe a response is appropriate in this instance.In filing this response novosource, llc makes no admission whatsoever that our implant is the cause of or has contributed in any manner to the alleged complaints enumerated in the patient's report.As the fda 3500-series form was incorrectly completed by the patient (initial reporter) and not qualified medical personnel, no additioanl information was given on other relevant history, including preexisting medical conditions.Novosource, llc generated an appropriate complaint form, completed a medical device reporting assessment, investigated potential root cause, and reviewed all available records (i.E.Dhr documentation, design records, and risk documentation).A root cause could not be effectively determined, however knee pain is a common side effect of total knee implant.

• Brand Name: NOVOKNEE
• Common Device Name: TOTAL KNEE
• Manufacturer (Section D): NOVOSOURCE, LLC; 1000 hampton center suite a; morgantown WV 26505
• Manufacturer (Section G): LINCOTEK MEDICAL; 9800 hillwood pkwy. ste. 140; fort worth TX 76177
• Manufacturer Contact: joshua vanmeter ; 1000 hampton ceneter suite a; morgantown, WV 26505 ; 3045542167
• MDR Report Key: 16286794
• Report Number: 3014273644-2022-00001
• Device Sequence Number: 11951468
• Product Code: JWH
• UDI-Device Identifier: 00811382031809
• UDI-Public: 00811382031809
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K131398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 3101-1202
• Device Catalogue Number: 3101-1202
• Device Lot Number: COR0022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2022
• Initial Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White