MAUDE Adverse Event Report: Moximed,Inc MISHA Knee System; Medial Knee Implanted Shock Absorber

Catalog Number	2-1001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The misha removal was completed without complication.The device was reported to be intact at time of removal.A review of manufacturing records indicates that the product conformed to design and manufacturing specifications.The cause of the event remains unknown.
Event or Problem Description
It was reported that patient underwent misha implantation for oa.More than 10 months later, the patient experienced knee stiffness, thought to be associated with lower back issues.The surgeon recommended a debridement procedure; however, the patient requested the removal of the device.The patient underwent misha removal, no further information was received.

• Brand Name: MISHA Knee System
• Common Device Name: Medial Knee Implanted Shock Absorber
• Manufacturer (Section D): Moximed,Inc; 46602 landing parkway; fremont CA 94538 -330
• Manufacturer (Section G): Moximed, Inc; 46602 landing parkway; fremont CA 94538 -330
• Manufacturer Contact: farhan shahab ; 46602 landing parkway; fremont, CA 94538--330 ; +1(510)887-3328
• MDR Report Key: 50885470
• Report Number: 3008274656-2026-00003
• Device Sequence Number: 10744766
• Product Code: QVV
• UDI-Device Identifier: 00856047005795
• UDI-Public: 00856047005795
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: DEN220033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: Health Professional
• Device Catalogue Number: 2-1001
• Device Lot Number: 25041601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2025
• 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: Required Intervention
• Patient Sex: Unknown