C-STEM 9612-12-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295235736), received between Jan 10, 2018 and Jan 27, 2025 — classified as 1 death, 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT WHEN PLACING THE CENTRALIZER ON THE STEM IT BROKE. NO FRAGMENTS WERE GENERATED. ANOTHER IMPLANT WAS USED. THERE WAS A FIVE MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21247575 ↗
• MalfunctionNov 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT WHEN PLACING THE CENTRALIZER ON THE, STEM IT BROKE. SURGERY WAS DELAYED BY FIVE MINUTES DUE TO THE EVENT. ANOTHER IMPLANT WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20726675 ↗
• MalfunctionMar 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THA SURGERY ON (B)(6) 2021. DURING THE SURGERY, WHEN A NURSE TRIED TO ATTACH THE CENTRALIZER IN QUESTION TO THE TIP OF THE STEM, THE CENTRALIZER CRACKED. IT IS NOT REPORTED HOW THE SURGERY WAS FINISHED. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11531871 ↗
• MalfunctionApr 26, 2019Fracture; Device Damaged Prior to Use; Fracture; Device Damaged Prior to Use

  THE SURGEON SAID THAT ON OPENING THAT THE VOID CENTRALIZER WAS DAMAGED AND SPLIT. THIS OCCURRED DURING SURGERY, WITH A 5 MIN DELAY WHILST AN ALTERNATIVE VOID CENTRALIZED WAS SOURCED, THE PERCEIVED DEFECTIVE PRODUCT WAS NOT IMPLANTED. NO AE TO PATIENT.

  Patient problems: Not Applicable

  MAUDE report 8555157 ↗
• MalfunctionFeb 21, 2019Fracture; Fracture

  EVENT: THE FINAL STEM, THE CENTRALIZER BROKE, SO IT HAD TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8357945 ↗
• DeathFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMMUNICATION RECEIVED. A DAUGHTER OF A PATIENT FROM (B)(6), CALLED UP REGARDING THE HIP REPLACEMENT COMPENSATION, IN REFERENCE TO THE NEWS SHE READ IN THE NEWSPAPER. SHE SAID THAT HER MOTHER HAD UNDERGONE A SURGERY OF TOTAL HIP REPLACEMENT IN THE YEAR 2014 AT A HOSPITAL IN (B)(6), AND IN (B)(6) 2015 HER MOTHER PASSED AWAY. THUS, SHE WANTS TO KNOW THE PROCEDURE TO CLAIM THE COMPENSATION AMOUNT .

  Patient problems: Death; Pain

  MAUDE report 8314625 ↗
• InjuryJan 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION THR DUE TO PERIPROSTHETIC FRACTURE, DR (B)(6), (B)(6) HOSPITAL (B)(6) 2017. PATIENT UNDERWENT PRIMARY THR ON (B)(6) 2017 -DR (B)(6), (B)(6). PATIENT WAS DOING WELL UNTIL A FALL 2 DAYS AGO. X RAYS INDICATE A PERI PROSTHETIC FRACTURE. THE FEMORAL STEM AND CEMENT WAS REMOVED AND A RECLAIM REVISION STEM IMPLANTED. THE PINNACLE CUP AND LINER WERE LEFT IN SITU. THE FRACTURE SIGHT WAS CIRCLAGED WITH A NUMBER OF CABLES. MALE PATIENT INITIALS (B)(6), AGED (B)(6) YEARS, DOB (B)(6). DOI; (B)(6) 2017; DOR: (B)(6) 2017; UNKNOWN AFFECTED SIDE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 7178328 ↗