C-STEM 9612-14-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295235811), received between May 22, 2018 and Feb 3, 2022 — classified as 2 injuries, 1 malfunction.

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

• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLACEMENT OF ANTIBIOTIC SPACER DUE TO THE PRESENCE OF INFECTION WAS DONE. THE CSTEM/PINNACLE TOTAL HIP CONSTRUCT WAS REMOVED AND REPLACED IT WITH A PROSTALAC SPACER. THERE WAS LOOSENING OF AN UNKNOWN CONSTRUCT AT THE BONE TO CEMENT INTERFACE. DOI: (B)(6) 2020. DOR: (B)(6) 2022. (LEFT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 13440408 ↗
• MalfunctionNov 14, 2018Fracture; Fracture

  DURING SURGERY SCRUB NURSE NOTICED VOID CENTRALIZER WAS CRACKED BEFORE INSERTION. VOID CENTRALIZER WAS DISCARDED AND ANOTHER WAS OPENED. NO DELAY TO PROCEDURE. NO AE TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8070722 ↗
• InjuryMay 22, 2018Fitting Problem; Fitting Problem

  THE REPORTED DEVICE WAS USED FOR THA (DATE OF PRIMARY SURGERY WAS UNKNOWN). DURING THE PRIMARY SURGERY, THE SURGEON COULD NOT INSERT THE STEM INTO THE FEMUR BECAUSE THE SIZE OF CENTRALIZER WAS LARGE. THE SURGEON TRIED TO PULL OUT THE STEM FOLLOWED BY THE CENTRALIZER, HOWEVER, THE SURGEON COULD NOT PULL OUT THE CENTRALIZER BECAUSE THE CEMENT WAS CURED WHILE TAKING OUT THE CENTRALIZER FROM INSIDE OF THE BONE. THUS, THE SURGEON BROKE THE CENTRALIZER IN THE CURED CEMENT WITH A REAMER, AND TOOK IT OUT. THE SURGERY WAS COMPLETED BY IMPLANTING SMALL SIZE OF THE STEM (P/N AND LOT NUMBER WERE UNKNOWN). A SURGICAL DELAY OF MORE THAN 30 MINUTES.

  Patient problems: Hip Fracture; No Code Available; Not Applicable

  MAUDE report 7533351 ↗