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

Catalog Number	2-1001
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	04/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of manufacturing records indicates that the product conformed to design and manufacturing specifications.At the time of misha implantation, additional procedures of medial meniscus root repair and synovectomy were performed.There is no information to suggest that the infection was caused by the misha product; the source of the post-operative infection remains unknown.This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company's complaint handling processes.This event is being filed in accordance with a capa which has been opened to manage the actions and any required mdr reporting.
Event or Problem Description
It was reported that patient underwent misha implantation for oa along with a medial meniscus root repair and synovectomy.About a month later, the patient had an irrigation and debridement due to reported pain and swelling.Cultures from the wound and were consistent with methicillin sensitive staphylococcus aureus (mssa).Three days later, a repeat irrigation and debridement with device removal was performed.About a month after the removal procedure, 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: 23595823
• Report Number: 3008274656-2025-00008
• Device Sequence Number: 18470806
• Product Code: QVV
• UDI-Device Identifier: 00856047005795
• UDI-Public: 00856047005795
• 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
• Device Explanted 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): 11/19/2025

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: 2-1001
• Device Lot Number: 25010305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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: Male