MAUDE Adverse Event Report: MOXIMED, INC. MISHA KNEE SYSTEM; MEDIAL KNEE IMPLANTED SHOCK ABSORBER, PRODUCT CODE: QVV

Catalog Number	2-1002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blood culture at the time of washout was positive for infection and a subsequent culture was negative.A review of manufacturing records indicates that the product conformed to design and manufacturing specifications.Prior to event, patient was reported to have an oral/gum ulcer.There is no information to suggest that the infection was caused by the misha product; the source of the post-operative infection remains unknown.
Event or Problem Description
It was reported that about 2.5 months after misha implantation, the patient received a washout due to a suspected infection.A picc line was started for antibiotics after which the patient was reported doing well.

• Brand Name: MISHA KNEE SYSTEM
• Common Device Name: MEDIAL KNEE IMPLANTED SHOCK ABSORBER, PRODUCT CODE: QVV
• Manufacturer (Section D): MOXIMED, INC.; 46602 landing parkway; fremont CA 94538
• Manufacturer (Section G): MOXIMED, INC.; 46602 landing parkway; fremont CA 94538
• Manufacturer Contact: vijaya krishnamoorthy ; 46602 landing parkway; fremont, CA 94538
• MDR Report Key: 23607462
• Report Number: 3008274656-2025-00010
• Device Sequence Number: 13073902
• Product Code: QVV
• UDI-Device Identifier: 00856047005801
• UDI-Public: 00856047005801
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: DEN220033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 11/20/2025

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: 2-1002
• Device Lot Number: 25042201
• 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: 10/24/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2025
• 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