CPCS 71312364Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010462039), received between Sep 17, 2018 and Jul 21, 2022 — classified as 5 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, 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 5 most recent of 5 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 THA SURGERY WAS PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT THAT LED TO A REVISION SURGERY ON (B)(6) 2018. THE STEM, FEMORAL HEAD AND LINER WERE EXPLANTED AND REPLACED. CURRENT HEALTH STATUS OF 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: Insufficient Information

  MAUDE report 15080891 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER A BHR SURGERY PERFORMED ON AN UNKNOWN DATE A REVISION SURGERY WAS PERFORMED TO REMOVE THE CPCS COCR PRIM SO 12/14 SZ 4 DUE TO LOOSENING. FURTHER INFORMATION IS UNKNOWN.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 14480037 ↗
• InjuryMay 27, 2019Fracture; Loose or Intermittent Connection; Fracture; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION HIP SURGERY WAS PERFORMED DUE TO FRACTURE CEMENT MANTLE AND SUBSIDENCE CPCS FEMORAL COMPONENT.

  Patient problems: Injury

  MAUDE report 8643495 ↗
• InjurySep 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY DUE TO INFECTION. PATIENT HAD RECENTLY A SECOND REVISION FOR INFECTION ON SAME HIP. UNFORTUNATELY, THE PATIENTS INFECTION PROGRESSED LEADING TO TODAY'S 3RD REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 7917260 ↗
• InjurySep 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REPLACE IMPLANTS STRYKER ALL POLY CUP, CPCS STEM AND HEAD DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7880963 ↗

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.