SAIPH 193-784Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055455507050), received between Mar 19, 2019 and Mar 19, 2019 — 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.

• MalfunctionMar 19, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A NOTIFICATION WAS RECEIVED ON 20FEB19. " A BOOKING WAS MADE BY (B)(6) ON (B)(6) 2019 FOR A CASE ON THE FOLLOWING WEEK ((B)(6) 2019). THE BOOKING WAS FOR A PATIENT WHO REQUIRED A SAIPH POLYETHYLENE EXCHANGE. (B)(6) PROVIDED MATORTHO WITH THE SAIPH COMPONENTS THAT THE PATIENT HAD IN-SITU TO ENABLE THE CORRECT SIZE POLYETHYLENE INSERTS TO BE SENT FOR THE CASE (SIZE E - BLUE). ON ARRIVAL AT (B)(6) ON (B)(6) 2019, I CHECKED THE IMPLANTS AND DISCOVERED THAT A SET OF GREEN E INSERTS HAD MISTAKENLY BEEN SENT. AS SUCH THE CASE COULD NOT GO AHEAD AND HAD TO BE CANCELLED." MATORTHO REFERENCE: (B)(4).

  Patient problems: Autoimmune Disorder; Patient Problem/Medical Problem

  MAUDE report 8432903 ↗