C-STEM 9612-46-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295236351), received between Nov 22, 2019 and Mar 30, 2020 — classified as 2 injuries.

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.

• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2013 VIA THA. IT WAS REPORTED THAT THERE WAS AN INDICATION OF INFECTION FOR SEVERAL YEARS, AND THE SURGEON HAD ADMINISTERED ANTIBIOTIC TO THE PATIENT AND FOLLOWED INFECTION¿S PROGRESS. HOWEVER, ON (B)(6) 2020, THE REMOVAL SURGERY WAS PERFORMED. THE SURGEON REMOVED THE CUP (P/N: 965328047), THE HEAD (P/N: 962734000), THE C-STEM (P/N: 961315000), THE CENTRALIZER (P/N: 961246000), THE END CAP (P/N: 961226000) AND THE CEMENT RESTRICTOR (P/N: 546014000) AND PLACED A CEMENT SPACE MOLDS. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9900800 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SECONDARY TO FOLLOW-UP INFORMATION RECEIVED, THIS PRODUCT IS NO LONGER CONSIDERED A SERIOUS INJURY AT THIS TIME.

  Patient problems: Not Applicable; Pain

  MAUDE report 9363226 ↗