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

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	06/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent misha implantation for oa with concomitant meniscal allograft, acl cyst removal and bone marrow aspirate injection.Approximately 4 months later, the patient presented with a surgical site infection with discharge from the distal end of the incision, redness and swelling.Irrigation and debridement of the wound was performed with removal of the misha device and planned post-op oral antibiotics.At the post-op visit a week later, the patient's wound was well-healed.
Additional Manufacturer Narrative
The event date is not known.The date of awareness of the event is reported as the event date.The misha knee system was reported to be well fixated and functioning at the time of removal.The removal was completed without complication.Wound cultures indicated s.Aureus infection.A review of manufacturing records indicates that the product conformed to design and manufacturing specifications.Analysis of the returned device found it to be intact and well-functioning.The source of the infection is unknown.Of note, at the time of misha implantation, additional procedures of meniscal allograft, acl cyst removal and bone marrow aspirate injection were performed.

• 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: 19761870
• Report Number: 3008274656-2024-00002
• Device Sequence Number: 8777649
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2025
• Device Catalogue Number: 2-1002
• Device Lot Number: 23032902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 07/17/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BONE MARROW ASPIRATE CONCENTRATE INJECTION; DEBRIDEMENT OF ANTERIOR ACL CYST; MEDIAL MENISCUS TRANSPLANT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 100 KG