SAIPH 193-602Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05055455506176), received between Oct 9, 2018 and Jun 13, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 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 STATING THAT A REVISION LEFT KNEE (SAIPH) WAS PLANNED FOR (B)(6) 2019. (B)(4).

  Patient problems: No Information

  MAUDE report 8694843 ↗
• MalfunctionOct 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A NOTIFICATION WAS RECEIVED AT MATORTHO LEATHERHEAD ON (B)(6) 2018 FROM MATORTHO AUSTRALIA PTY. STATING THAT A SAIPH REVISION HAD OCCURED ON (B)(6) 2018. THE PATIENT REQUIRED REVISION TOTAL KNEE ARTHROPLASTY. THE TIBIAL COMPONENT WAS LOOSE AND HAD SUBMERGED. ALL IMPLANTS WERE EXPLANTED AND AN ALTERNATIVE KNEE SYSTEM WAS REQUIRED. MATORTHO REFERENCE: (B)(4).

  Patient problems: Autoimmune Disorder

  MAUDE report 7946266 ↗