MISHA® Knee System, Small, Right 2-1002Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00856047005801), received between Jul 17, 2024 and Nov 20, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Dec 2, 2024Open, Classified

   Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry at the distal end of the absorber component that may result in a reduced wall thickness and microcracks, which may lead to new or worsening symptoms of discomfort, swelling / edema, pain or stiffness, which may necessitate removal of the device.

   Z-0762-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ABOUT 2.5 MONTHS AFTER MISHA IMPLANTATION, THE PATIENT RECEIVED A WASHOUT DUE TO A SUSPECTED INFECTION. A PICC LINE WAS STARTED FOR ANTIBIOTICS AFTER WHICH THE PATIENT WAS REPORTED DOING WELL.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23607462 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD MISHA IMPLANTATION FOR OA AND 42 DAYS LATER UNDERWENT IRRIGATION AND DEBRIDEMENT DUE TO SUSPECTED SUTURE ABSCESS WITH REMOVAL OF THE PROXIMAL-MOST SCREW. ANOTHER 10 DAYS LATER, THE PATIENT UNDERWENT A REPEAT IRRIGATION AND DEBRIDEMENT WITH DEVICE REMOVAL.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23595603 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT MISHA IMPLANTATION FOR OA ALONG WITH ARTHROSCOPY. TWO DAYS LATER, THE PATIENT EXPERIENCED REDNESS, SWELLING, AND DRAINAGE FROM THE INCISION. TEN DAYS AFTER IMPLANTATION, THE PATIENT HAD A WOUND WASHOUT AND A PICC LINE FOR INFECTION WAS STARTED. THE PATIENT'S WOUND AND KNEE PAIN IMPROVED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23595292 ↗
• MalfunctionSep 9, 2025Fracture; Fracture

  PATIENT REPORTED MEDIAL KNEE PAIN. FRACTURE AT THE TIBIAL END OF THE ABSORBER WAS OBSERVED ON X-RAY. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY.

  Patient problems: Implant Pain

  MAUDE report 23011837 ↗
• MalfunctionNov 8, 2024Fracture; Fracture

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641246 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Post Operative Wound Infection

  MAUDE report 19761870 ↗