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	09/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had misha implantation for oa and 42 days later underwent irrigation and debridement due to suspected suture abscess with removal of the proximal-most screw.Another 10 days later, the patient underwent a repeat irrigation and debridement with device removal.
Additional Manufacturer Narrative
The misha removal was completed without complication.The pathology report was consistent with suture abscess and localized, superficial infection.A review of manufacturing records indicates that the product conformed to design and manufacturing specifications.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.

• 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: 23595603
• Report Number: 3008274656-2025-00007
• Device Sequence Number: 9317612
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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 Expiration Date: 09/25/2025
• Device Catalogue Number: 2-1002
• Device Lot Number: 23092503
• 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: 09/03/2024
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2023
• 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