CPCS 71312372Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010462152), received between May 5, 2018 and Jan 18, 2024 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 18, 2024Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR WAS PERFORMED ON (B)(6) 2017, IT WAS NOTICED FROM THE X-RAY ON 23-DEC-2023 THAT THE PATIENT PRESENTED WITH PERI-PROSTHETIC FRACTURE OF THE RIGHT PROXIMAL FEMUR. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, IN WHICH A COCR 12/14 FEM HEAD 36MM +4 AND A CPCS COCR PRIM HO 12/14 SZ 2 WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 18540384 ↗
• 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) 2010, THE PATIENT EXPERIENCED A PERI-PROSTHETIC FRACTURE AROUND THE CPCS COCR PRIM HO 12/14 SZ 2 PROSTHESIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL THE COMPONENTS FROM THE PROSTHESIS CONSTRUCT WERE EXPLANTED. THE PATIENT'S OUTCOME 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 15089935 ↗
• 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 WAS PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED A PERIPROSTHETIC FRACTURE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2019, WHERE THE STEM WAS 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: Hip Fracture

  MAUDE report 15080519 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR HAD BEEN PERFORMED ON (B)(6) 2021 THE CPCS COCR PRIM HO 12/14 SZ 2 HAS MALTRACKED ON INSERTION. THIS ADVERSE EVENT WAS SOLVED WITH REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12318847 ↗
• InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A PERIPROSTHETIC FRACTURE. DR PLATED HER FEMUR AND CABELLED AROUND THE EXISTING PROSTHESIS.

  Patient problems: Bone Fracture(s)

  MAUDE report 8981175 ↗
• InjurySep 10, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE STEM BEING LOOSE AFTER A FRACTURE.

  Patient problems: Injury

  MAUDE report 8980067 ↗
• InjuryMay 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO THE PATIENT DUE TO AN INFECTION. THREE DEVICES EXPLANTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 8601009 ↗
• MalfunctionJan 30, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING SURGERY, LASER MARKING ON CPCS STEM IMPLANT WERE FAINTER THAN NORMAL AND HARD TO SEE. STEM WAS INSERTED DEEPER THAN NORMAL. SURGERY COMPLETED WITH 5 MINUTE DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8288338 ↗
• InjuryMay 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRODUCT EXPERIENCE. ORIGINAL SURGERY: DR (B)(6) APPROX 2 WEEKS AGO (B)(6). REVISION CAUSE: INFECTION. CASE: CPCS SIZE 2 HO CEMENTED STEM REMOVED. CPCS SIZE 1 HO STEM IMPLANTED IN REMAINING CEMENT MANTLE. SIZE 36 +8 COBALT CHROME HEAD REMOVED. NEW HEAD IMPLANTED (SAME SIZE AND MATERIAL). NO REPORT REQUIRED FOR SURGEON. SURGEON HAS NOT IMPLICATED IMPLANT AS A CAUSE OF REVISION . NO HOSPITAL REPORT REQUIRED . IMPLANT WILL NOT BE RETURNED TO THE HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 7489374 ↗

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.