MISHA® Knee System, Small, Left 2-1001Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00856047005795), received between Apr 9, 2024 and Sep 24, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient underwent MISHA implantation for OA. More than 10 months later, the patient experienced knee stiffness, thought to be associated with lower back issues. The surgeon recommended a debridement procedure; however, the patient requested the removal of the device. The patient underwent MISHA removal, no further information was received.

  Patient problems: Loss of Range of Motion

  MAUDE report 50885470 ↗
• MalfunctionJun 12, 2026Fracture

  FRACTURE AT THE TIBIAL END OF THE ABSORBER WAS OBSERVED ON X-RAY. NO FURTHER TREATMENT HAS BEEN REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25490216 ↗
• 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 ARTHROSCOPIC MEDIAL MENISCECTOMY AND CHONDROPLASTY OF THE PATELLA AND LATERAL TIBIAL PLATEAU WITH SOME LOSS OF MOTION PRIOR TO THE MISHA PROCEDURE. MORE THAN 6 MONTHS LATER, THE PATIENT EXPERIENCED LOSS OF MOTION AND UNDERWENT ARTHROSCOPIC DEBRIDEMENT, ANTERIOR AND POSTERIOR CAPSULE RELEASE REGAINING RANGE OF MOTION. THE PATIENT EXPERIENCED LOSS OF MOTION AGAIN AND UNDERWENT MISHA REMOVAL AND FULL RANGE OF MOTION WAS NOTED.

  Patient problems: Loss of Range of Motion

  MAUDE report 23596128 ↗
• 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 A MEDIAL MENISCUS ROOT REPAIR AND SYNOVECTOMY. ABOUT A MONTH LATER, THE PATIENT HAD AN IRRIGATION AND DEBRIDEMENT DUE TO REPORTED PAIN AND SWELLING. CULTURES FROM THE WOUND AND WERE CONSISTENT WITH METHICILLIN SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA). THREE DAYS LATER, A REPEAT IRRIGATION AND DEBRIDEMENT WITH DEVICE REMOVAL WAS PERFORMED. ABOUT A MONTH AFTER THE REMOVAL PROCEDURE, THE PATIENT WAS REPORTED DOING WELL.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23595823 ↗
• 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 A PARTIAL MENISCECTOMY. FIVE DAYS LATER, THE PATIENT PRESENTED WITH PUS AT THE WOUND AND RECEIVED A WASHOUT AND ANTIBIOTICS. FIFTEEN DAYS AFTER IMPLANTATION, THE DEVICE WAS REMOVED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23594916 ↗
• MalfunctionApr 2, 2025Fracture; Fracture

  FRACTURE AT THE FEMORAL END OF THE ABSORBER WAS OBSERVED ON X-RAY AT ANNUAL DOCTOR'S VISIT. PATIENT COMMENTED ON TENDERNESS AROUND THE IMPLANT. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY.

  Patient problems: Implant Pain

  MAUDE report 21752756 ↗
• MalfunctionJan 31, 2025Fracture; Fracture

  FRACTURE AT THE TIBIAL END OF THE ABSORBER WAS OBSERVED ON X-RAY. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283985 ↗
• InjuryApr 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  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.

  Patient problems: Swelling/ Edema

  MAUDE report 19070568 ↗