CPCS 71312370Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010462138), received between Aug 18, 2019 and Aug 22, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

1 other recall cover devices cleared under the same FDA submission (K211176, K240783, K970351); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER HAVING A PRIMARY SURGERY IN WHICH A CPCS STEM WAS IMPLANTED, ONE (1) PATIENT UNDERWENT A REVISION SURGERY DUE TO A PERI-PROSTHETIC FRACTURE. NO FURTHER INFORMATION IS AVAILABLE. THE CURRENT STATE OF HEALTH OF THE PATIENTS IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 20024404 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT THR PERFORMED ON (B)(6) 2008 THE PATIENT PRESENTED A PERIPROSTHETIC FRACTURE ON THE FEMUR. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6)2015 WHERE THE FEMORAL STEM WAS EXPLANTED. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT EITHER A REVISION OR RE-REVISION SURGERY WHERE A POLARCUP SHELL WAS PART OF THE HIP CONSTRUCT. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Hip Fracture

  MAUDE report 15080568 ↗
• InjuryAug 18, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF STEM WITH OSTEOLYSIS AT THE FEMUR AND ACETABULUM, AND RECURRENT DISLOCATIONS.

  Patient problems: Injury

  MAUDE report 8904427 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K240783, K970351. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.