CPCS 71312360Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010461995), received between Aug 26, 2019 and Jul 22, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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. How this data works · Data updated Oct 13, 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.

• 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 THR REVISION SURGERY, WHERE A CPCS COCR PRI SO 12/14 SZ 0 WAS IMPLANTED, ON (B)(6) 2020 THE PATIENT UNDERWENT A REVISION SURGERY TO EXPLANT FEMORAL STEM DUE TO A PERI-PROSTHETIC FRACTURE ASSOCIATED TO THE FEMUR. CURRENT HEALTH STATUS OF THE PATIENT 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 15089945 ↗
• InjuryMar 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER A THR PROCEDURE, THE PATIENT HAS UNDERGONE RECURRENT DISLOCATIONS DUE TO SOFT TISSUE LAXITY. FOR THIS REASON, REVISION SURGERY WAS PERFORMED AND THE STEM WAS REMOVED TO GAIN ACCESS TO THE ACETABULUM (STEM WAS WELL FIXED, WELL-POSITIONED) AND REPLACED WITH A SAME-SIZED STEM. ALL EXPLANTED IMPLANTS HAVE BEEN DISCARDED.

  Patient problems: Joint Dislocation

  MAUDE report 9788320 ↗
• InjuryAug 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO A TUMOR INGRESS.

  Patient problems: Injury

  MAUDE report 8929137 ↗

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.