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

Catalog Number	2-1001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is being reported due to the device removal scheduled as a result of the device malfunction.Once explanted and returned, and the investigation is completed, a follow-up report will be submitted.
Event or Problem Description
Clinical trial patient in europe experienced a cracking sound and felt clicking.On examination, the patient had swelling/hydrops, retropatellar crepitations during mobilization.Knee remains stable with full range of motion.X-ray showed device malfunction.Device removal is scheduled.
Additional Manufacturer Narrative
This supplemental report is being provided due to the device removal which took place after the initial report of device malfunction was submitted.An update on the investigation is also being provided.A review of manufacturing records indicates that the product conformed to design and manufacturing specifications.The device was returned, and the malfunction was confirmed on analysis.A sudden giving way of the knee may lead to instability, potential falls and possible distortion of the knee into non physiological positions.The knee was and remains stable.The knee giving way events are likely associated with the presence of knee oa or weak quadriceps.Given the temporal proximity of the knee giving way and subsequent sensation of device clicking, it is reasonable to link the giving way event as a cause of the malfunction.
Event or Problem Description
This supplemental report is being provided due to the device removal which took place after the initial report of device malfunction was submitted.Clinical trial patient in europe experienced an episode of the knee giving way, cracking sound and felt clicking.On examination, the patient had swelling/hydrops, retropatellar crepitations during mobilization, no medial/lateral or ap knee instability and full range of motion.X-ray showed device malfunction.The patient reported knee giving way experiences prior to and after device implantation, and immediately preceding the event.Device was removed approximately a month later.The event resolved, patient reported to be doing well with slight medial swelling and full range of motion.

• 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: 19070568
• Report Number: 3008274656-2024-00001
• Device Sequence Number: 19998177
• Product Code: QVV
• UDI-Device Identifier: 00856047005795
• UDI-Public: 00856047005795
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: DEN220033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2020
• Device Catalogue Number: 2-1001
• Device Lot Number: 18102405
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2018
• 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 Age: 39 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White