CPCS 71312410Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010466983), received between May 3, 2018 and Jan 19, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• InjuryJan 19, 2021Break; Break

  IT WAS REPORTED THAT DURING A CEMENTED HIP REPLACEMENT USING CPCS, THE 10MM CENTRALISER SPLIT OPEN WHEN FITTED TO THE TIP OF THE STEM. THIS DEVICE WAS DISCARDED. ANOTHER 10MM CENTRALISER WAS OPENED. THE SURGEON NOTICED THAT IT HAD ABNORMAL MATERIAL QUALITIES "LIKE GLASS". IT FAILED IN THE SAME WAY, BUT WAS NOT THROWN AWAY - IT IS AVAILABLE FOR RETURN AND INSPECTION. THE SURGERY WAS COMPLETED WITH ANOTHER S+N DEVICE. THERE WAS A DELAY LESS THAN OR EQUAL TO 30 MINUTES.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197402 ↗
• InjuryJan 19, 2021Break; Break

  IT WAS REPORTED THAT DURING A CEMENTED HIP REPLACEMENT USING CPCS, THE 10MM CENTRALISER SPLIT OPEN WHEN FITTED TO THE TIP OF THE STEM. THIS DEVICE WAS DISCARDED. ANOTHER 10MM CENTRALISER WAS OPENED. THE SURGEON NOTICED THAT IT HAD ABNORMAL MATERIAL QUALITIES "LIKE GLASS". IT FAILED IN THE SAME WAY, BUT WAS NOT THROWN AWAY - IT IS AVAILABLE FOR RETURN AND INSPECTION. THE SURGERY WAS COMPLETED WITH ANOTHER S+N DEVICE. THERE WAS A DELAY LESS THAN OR EQUAL TO 30 MINUTES.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197385 ↗
• InjuryJan 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. STEM, HEAD AND ACETABULAR LINER REMOVED.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8276353 ↗
• InjuryMay 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LOAN: (B)(4). PRODUCT EXPERIENCE ORIGINAL SURGERY: DR (B)(6) APPROX 2 WEEKS AGO (B)(6). REVISION CAUSE: INFECTION. CASE: CPCS SIZE 2 HO CEMENTED STEM REMOVED. CPCS SIZE 1 HO STEM IMPLANTED IN REMAINING CEMENT MANTLE. SIZE 36 +8 COBALT CHROME HEAD REMOVED. NEW HEAD IMPLANTED (SAME SIZE AND MATERIAL). NO REPORT REQUIRED FOR SURGEON. SURGEON HAS NOT IMPLICATED IMPLANT AS A CAUSE OF REVISION . NO HOSPITAL REPORT REQUIRED. IMPLANT WILL NOT BE RETURNED TO THE HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 7485629 ↗