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

Catalog Number	2-1001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Fracture at the femoral end of the absorber was observed on x-ray at annual doctor's visit.Patient commented on tenderness around the implant.
Additional Manufacturer Narrative
A device removal is planned.If/when explanted, returned, and the investigation is completed, a follow-up report will be submitted.
Additional Manufacturer Narrative
Available post-operative radiographs indicate that the femoral base was malpositioned at time of implantation, indicative of intraoperative user error.The retrieval analysis identified impingement marks on the piston neck and femoral socket confirming malpositioning of the femoral base relative to the absorber.A review of manufacturing records indicates that the fractured component conformed to manufacturing specifications.
Event or Problem Description
Fracture at the femoral end of the absorber was observed on x-ray at annual doctor's visit.Patient commented on tenderness around the implant.The device was removed without difficulty.

• Brand Name: MISHA KNEE SYSTEM
• Common Device Name: MEDIAL KNEE IMPLANTED SHOCK ABSORBER
• Manufacturer (Section D): MOXIMED, INC.; 46602 landing parkway; fremont CA 94538 3300
• Manufacturer (Section G): MOXIMED, INC.; 46602 landing parkway; fremont CA 94538 3300
• Manufacturer Contact: vijaya krishnamoorthy ; 46602 landing parkway; fremont, CA 94538-3300 ; 5108873366
• MDR Report Key: 21752756
• Report Number: 3008274656-2025-00003
• Device Sequence Number: 9822088
• Product Code: QVV
• UDI-Device Identifier: 00856047005795
• UDI-Public: 00856047005795
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2025
• Device Catalogue Number: 2-1001
• Device Lot Number: 23032901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• 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
• Patient Sex: Female