CPCS 71312375Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010462183), received between May 21, 2021 and Jul 21, 2022 — 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.

• 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 THA HAD BEEN PERFORMED ON (B)(6) 2010, THE PATIENT EXPERIENCED A PERI-PROSTHETIC FRACTURE NEAR THE FEMORAL STEM AREA. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE FEMORAL STEM WAS EXPLANTED. THE PATIENT'S HEALTH STATUS IS UNKNOWN. 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 15080562 ↗
• InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR PERFORMED IN (B)(6) 2013, AS A REVISION SURGERY FOR INFECTION OF NON SMITH AND NEPHEW DEVICES, THE PATIENT EXPERIENCED PAIN IN THE RIGHT HIP AND A POSSIBLE RECURRENT INFECTION WAS SUSPECTED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THESE ADVERSE EVENTS. THE OXINIUM FEM HD 12/14 36 MM +0 (CASE: (B)(4)), THE R3 20 DEG XLPE ACET LNR 36MM X 60MM (CASE: (B)(4)), THE CPCS COCR PRIM HO 12/14 SZ 5 (CASE: (B)(4)), AND THE CPCS DIST CENT SZ 16MM (CASE: (B)(4)) WERE EXPLANTED. IT IS UNKNOWN WHICH NEW DEVICES WERE IMPLANTED. NO OTHER COMPLICATIONS WERE REPORTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 11861825 ↗

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.