MAUDE Adverse Event Report: MOXIMED, INC. MISHA KNEE SYSTEM; 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	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fracture at the tibial end of the absorber was observed during the device removal and confirmed on initial analysis of the device.The investigation into the root cause is ongoing, including metallurgical analysis.When the investigation is complete, a follow-up report will be submitted.
Event or Problem Description
Patient had misha knee system implantation with concomitant posterior medial meniscal root tear repair.Patient experienced ongoing predominantly femoral knee pain.The patient underwent chondroplasty, lysis of adhesions, and device removal.During the device removal, the tibial end of the absorber was noted to have a fracture.The device was removed without difficulty.
Additional Manufacturer Narrative
The fracture at the tibial end of the absorber was observed during the device removal and confirmed on initial analysis of the device.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.

• Brand Name: MISHA KNEE SYSTEM
• Common Device Name: IMPLANTED SHOCK ABSORBER
• Manufacturer (Section D): MOXIMED, INC.; 46602 landing parkway; fremont CA 94538
• Manufacturer (Section G): MOXIMED, INC.; 46602 landing parkway; fremont CA 94538
• Manufacturer Contact: nancy isaac ; 46602 landing parkway; fremont, CA 94538 ; 5108873366
• MDR Report Key: 20641246
• Report Number: 3008274656-2024-00003
• Device Sequence Number: 7367217
• Product Code: QVV
• UDI-Device Identifier: 00856047005801
• UDI-Public: 00856047005801
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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
• Date Returned to Manufacturer: 10/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/13/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3008274656/12022024/R000
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: POSTERIOR MEDIAL MENISCUS ROOT REPAIR.
• Patient Sex: Male