C-STEM 9612-10-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295235682), received between May 25, 2018 and Jul 28, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient needed revision due to instability.DOI: (b)(6) 2019.DOR: (b)(6) 2026.Affected side: Left hip.

  Patient problems: Joint Laxity

  MAUDE report 50061388 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COMPONENTS WERE REMOVED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13257799 ↗
• MalfunctionDec 14, 2020Fracture; Fracture

  THE VOID CENTRALIZER WAS PUT ONTO THE END OF THE C-STEM IMPLANT BEFORE IMPLANTING AND A NOTICEABLE AUDIBLE CRACK WAS HEARD, THE PLASTIC CENTRALIZER HAD CRACKED. IT¿S UNCLEAR IF THE VOID CENTRALIZER WAS PUT INTO THE END OF THE C-STEM WITH EXCESSIVE FORCE OR NOT. THE SURGEON AGREED TO GOING UP IN SIZE FOR THE CENTRALIZER AS THERE¿S ONLY 1 SET CONSIGNED AT THE HOSPITAL. THE CRACKED PLASTIC CENTRALIZER WAS DISCARDED BY THE HOSPITAL AS IT IS SMALL AND DIFFICULT TO STERILIZE. STICKERS FOR BOTH CENTRALIZERS WERE PLACED ON THE IMPLANT USAGE SHEET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11002994 ↗
• InjuryMay 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2017. IT WAS REPORTED THAT REMOVAL SURGERY WAS PERFORMED TO EXPLANT THE IMPLANTS DUE TO THE INFECTION (THE DATE OF REMOVAL WAS UNKNOWN). NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. DOI: (B)(6) 2017; DOR: UNKNOWN; UNKNOWN HIP.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7544863 ↗