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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Fracture at the tibial end of the absorber was observed on x-ray.No further treatment has been reported at this time.
Additional Manufacturer Narrative
The root cause is a supplier error.An incorrect drill was used resulting in an inaccurate drill point angle and reduced material thickness.This might increase the risk of implant fracture in one lot where the supplier error occurred.A follow-up report will be submitted if any significant new information is obtained.

• 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: farhan shahab ; 46602 landing parkway; fremont, CA 94538-3300 ; 5108873366
• MDR Report Key: 25490216
• Report Number: 3008274656-2026-00001
• Device Sequence Number: 16082446
• Product Code: QVV
• UDI-Device Identifier: 00856047005795
• UDI-Public: 00856047005795
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: DEN220033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

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
• Device Expiration Date: 03/29/2025
• Device Catalogue Number: 2-1001
• Device Lot Number: 23032901
• 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: 05/13/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3008274656/12022024/R/00
• Patient Sequence Number: 1
• Patient Sex: Unknown