Medial Rotation Knee 156-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055455503397), received between May 23, 2017 and May 23, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  A NOTIFICATION WAS RECEIVED STATING THAT AN MRK¿ SIZE 2 FEMUR (AND BESPOKE GUIDES FOR CASE (B)(4)) (LEFT) WAS REVISED TO A HINGED KNEE WITHIN 1 MONTH OF THE PRIMARY OPERATION. THE PRIMARY OPERATION DATE WAS REPORTED TO BE (B)(6) 2017. IT WAS STATED THAT OSTEOPHYTES PREVENTED PROPER FITTING OF A BESPOKE FEMORAL GUIDE. WITH APPLICATION OF FORCE, THE GUIDE WAS FITTED TO THE PATIENT ANATOMY AND APPEARED TO FIT SECURELY DESPITE A FRACTURE [OF THE GUIDE] AT THE TOP RIGHT. THE PROCEDURE WAS CONTINUED WITH THE BESPOKE HAVING GUIDED THE CUTTING GUIDE POSITIONS, HOWEVER THE ANTERIOR FEMORAL CUT INTRODUCED A LARGE NOTCH. (B)(4).

  Patient problems: No Information

  MAUDE report 6584873 ↗