C-STEM 9611-74-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295235286), received between Nov 22, 2019 and Oct 16, 2024 — classified as 3 injuries.

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

• InjuryOct 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO AN IMPLANT FRACTURED.

  Patient problems: Insufficient Information

  MAUDE report 20460554 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PERIPROSTHETIC FRACTURE. DOI; 2003. DOR: (B)(6) 2021; RIGHT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 12103669 ↗
• InjuryNov 22, 2019Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON NOV 26TH, 2009 VIA THA. THE PATIENT COMPLAINED OF A PAIN AND IT WAS PERFORMED ARTHROCENTESIS HOWEVER THERE WAS NO ABNORMALITY IN JOINT FLUID ETC. AND THERE WAS NO SWELLING. IT WAS REPORTED THAT THE REVISION SURGERY WAS SCHEDULED TO BE PERFORMED ON NOV 20TH, 2019 BY REPLACING THE STEM (P/N: 961174000), THE END CAP (P/N: 961226000), THE CENTRALIZER (P/N: 961246000), THE CEMENT RESTRICTOR (P/N: 546016000), THE HEAD (P/N: 962711000),THE LINER (P/N: 121887354), THE CUP (MANUFACTURED BY KYOCERA, P/N: 121780054, LOT#: 00797) WITH 3 SCREWS (MANUFACTURED BY KYOCERA, P/NS: 556070J, LOT#S: 02327, 02241, 02239) BECAUSE HE STILL HAD AN INTENSE PAIN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Not Applicable; Pain

  MAUDE report 9363256 ↗