SAIPH 193-773Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055455506947), received between Oct 9, 2018 and Oct 9, 2018 — 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 16, 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.

• MalfunctionOct 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  NOTIFICATION WAS RECEIVED STATING THAT "THE PATIENT REQUIRED REVISION KNEE SURGERY (INSERT CHANGE) POST PRIMARY TKR. PATIENT HAD A FALL 6/52 POST TKR AND RUPTURED QUADRICEPS MUSCLE. SURGEON PERFORMED AN ARTHROTOMY BUT PATIENT STILL ACHIEVING 10 DEGREES OF HYPERFLEXION. REVISION TKR WAS THEN PLANNED AND PERFORMED (B)(6) 2018, 12MM INSERT EXPLANTED, 18MM INSERTED IMPLANTED (193-776, LOT 201245)". MATORTHO REFERENCE: (B)(4).

  Patient problems: Fall

  MAUDE report 7946270 ↗