CPCS 71312373Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010462169), received between Jul 22, 2022 and Aug 13, 2024 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K211176, K823727); 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. How this data works · Data updated Oct 13, 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.

• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON A POST-MARKET CLINICAL FOLLOW-UP ACTIVITY FOR CPCS HIP SYSTEMS, IT WAS REPORTED THAT, AFTER UNDERGOING LEFT THR ON (B)(6) 2022 DUE TO AVASCULAR NECROSIS OF THE LEFT FEMORAL HEAD AND LEFT HIP ABDUCTOR TENDON TEAR, ONE (1) PATIENT SUSTAINED A PERIPROSTHETIC FRACTURE OF THE TIP OF THE GREATER TROCHANTER WITH HEMATOMA THAT WAS IDENTIFIED AT 8 WEEKS POSTOPERATIVELY ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING ANY ADDITIONAL INTERVENTION TO TREAT THIS FRACTURE & HEMATOMA.

  Patient problems: Hematoma; Hip Fracture; Pain

  MAUDE report 19972574 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THA HAD BEEN PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED A PERI-PROSTHETIC FRACTURE ASSOCIATED TO THE STEM PROSTHESIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE CPCS COCR PRIM HO 12/14 SZ 3 WAS EXPLANTED. THE PATIENT'S HEALTH STATUS IS NOT KNOWN. 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 15089980 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K823727. 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.